fbpx Skip to main content

Conference Case Studies

Enhancement of Wound StO2 with Best Practice TIMERS Methodology and Utilization of Cellular,
Acellular and Matrix-Like Products (CAMPs)

Introduction

The proliferative phase of wound healing is associated with the formation of granulation tissue which represents the onset of neo-angiogenesis. Matrix formation is critical to support wound proliferation which then allows for fibroblast replication and function which is then followed by epithelialization, wound closure, and healing. A variety of advanced Cellular, Acellular and Matrix-Like Products (CAMPs) have come to the Wound Healing Market over the years. CAMPs technologies are available for the Wound Care Providers to use to manage compromised ulcers on Complex Patients. As wounds/ulcers progress through the phases of wound healing, non-healing/chronic wounds become stalled in the inflammatory phases of healing.

Discussion

Near infra-red spectroscopy (NIRS) has been used to evaluate tissue oxygen saturation
(StO2) through the phases of wound healing to assist the Wound Care Providers on their Plan of Care and expectation towards wound healing progression or regression with Chronic Ulcers. This case series illustrates enhancement of wound base StO2 using NIRS to assess for adequate wound bed preparation and integration of the product and reapplication process following wound management with a variety of CAMPs since each patient is uniquely different and responds to these advanced technologies differently.

Granulation tissue is thought to be associated with increased tissue oxygenation and
perfusion. Historically, this premise has been hypothetical as providing subjective
supportive data of increased tissue oxygenation has been limited to benchtop and invitro
methods of analysis. NIRS is a point of care imaging modality that uses near infrared light to provide an instantaneous assessment of tissue oxygenation. Using NIRS to monitor the progress of therapeutic intervention is helpful in assessing the effectiveness and response to the decided advanced technologies including CAMPs intervention and plan of care.

Providers are improving outcomes and reducing complications with NIRS point of care
diagnostic technology. The providers could identify in real time the microcirculation tissue oxygen in the wound bed. These results impact in the moment decision making for plan of care.

Methods

Wound Care Providers followed best practices standard of therapy (TIMERS) protocols to evaluate and manage any underlying comorbidities/conditions. Next, they identified the best CAMPs technology on their formulary to meet the criteria of these complicated/
complex wounds/ulcers. NIRS is a non-invasive imaging device that can measure
oxygenated and deoxygenated levels of hemoglobin in the wound and periwound tissues
to calculate tissue oxygen saturation. A series of cases is presented to demonstrate the
effectiveness of these CAMPs technologies in promoting granulation tissue, increasing
wound base oxygenation using SnapshotNIR.

Results

This study is the first of many to demonstrate enhancement in tissue oxygenation and
perfusion through the duration of wound management and following the application of
CAMPs which correlates to improved wound healing trajectories. NIRS should be
considered to complement clinical management strategies to enhance monitoring of
wound progress and complement the assessment of the response of a compromised
wound to a therapeutic plan.

References

Captions:

Pt #1 – 60-year-old male with a Stage 4 Sacral Pressure Injury patient states he was hospitalized for failure to thrive and was in the hospital for several weeks. Onset 8/21/23, 1st visit 9/26/23 44.86 sq cm with and 4.0cm depth standard care including patient education, nutrition, offloading, infection management, surgical debridements, advanced wound care dressings and NPWT. Initiated CAMPS on 11/4/23 27.56 sq cm, 2.2cm depth & undermining
of 1.8 cm after the 4th application of CAMPS the depth improved from 2.2 cm to 0.7cm and the undermining improved from 1.8 cm to 0 undermining. After the last application wound is measuring 5.28 sq cm with 0.1 cm depth. NIRS imaging 65% in wound bed pre- debridement and 80% post debridement. Goals showing improvement outcomes with surgical debridement and changes in StO2 oxygen saturation post debridement.

Pt #2 – 73-year-old female presents with a wound LLE secondary to a dog jumping on her and scratching her and it progressively was just getting worse – Onset 1/8/24 26.65 sq cm depth 0.1cm standard therapy initiated, concerns with refractory status due to age & underlying comorbidities. Fluorescence Imaging obtained, and NIRS images and interpretation 79% tissue oxygen situation in wound bed representation adequate StO2 to support wound healing. CAMPS applications initiated after several applications. Wound size is now 2.24 sq cm progressing towards wound healing.

Pt #3 – 99-year-old female with history of CHF, HTN, lymphedema and chronic venous insufficiency with multiple ulcers on both legs, onset at least a year prior to her 1st visit with our Mobile Wound Management Program. Standard of Care has been implemented including arterial assessment, compression management etc. In addition, fluorescence Imaging to determine bacteria loads status determining it was (-), NIRS anterior lateral – 60% oxygen saturation pre-debridement, 75% post-debridement, lateral – 57% oxygen saturation pre-debridement, 73% post-debridement. Representing adequate tissue oxygen saturation. The provider’s plan of care was decided to add the CAMPS modalities at the next visit.

Against All Odds – Presenting a Patient Centered Wholeness Approach Involving a Morbidly Obese Patient with B/L Post Upper Leg Pressure Ulcers

Introduction 

The management of pressure ulcers affecting morbidly obese patients who are bed-chair bound is a challenging scenario that requires multiple levels of care to aid in wound healing. Patients frequently present with different conditions slowing their wound healing down significantly. These include urinary incontinence, Irritable Bowel Syndrome, diarrhea, excess moisture leading to fungal and bacterial overgrowth within the adipose folds, difficulty moving and positioning due to weight, along with multiple comorbidities such as restrictive lung disease, obstructive sleep apnea, congestive heart failure, and fatty liver disease to list a few. These challenges prolong wound healing for years on many occasions.

The particular patient in this case study was a 61 year old female. Some of her comorbidities include morbid obesity, congestive heart failure, and mental health issues. Due to these conditions, she is wheelchair and bed-bound, which led to many of her wounds. The patient also had monetary and food security issues which further led to the constant state of non-healing wounds.

Methods

With this patient, we controlled every possible condition that was directly associated with her wound healing. To name a few: offloading, nutritional status including supplements such as protein, vitamin D, and collagen peptides, infection management, incontinence, advanced wound therapy including a dual-layered dehydrated human amnion membrane (dHAM) comprised primarily of connective tissue. It preserves the natural growth factors and cytokines normally present in amniotic tissue. The connective tissue and associated factors allow the soft tissue to regenerate, promote granulation and wound closing. Most importantly we focused on the patient’s emotional well-being to provide a calm reassuring atmosphere during each visit.

Discussion

The aim of this case presentation is to highlight the “kitchen sink” approach in these very challenging cases and scenarios. Advanced technologies and therapies included negative pressure wound therapy, vibrating mechanical debridement, and fluorescence imaging to monitor and guide the provider to develop a plan of care for managing the high level of bacteria load. The vibrating mechanical debridement tool (VMDT) was especially useful because the patient did not respond well to traditional debridement methods. Used in conjunction with the fluorescence imaging, we were able to properly clean the wounds and safely disrupt biofilm.

The provider obtained before and after fluorescence Imaging to develop a plan of care. Before images reflected (+) red fluorescence indicating bacterial loads greater than 10.4 which may indicate bioburdens at risk for infection. Post VMDT scrubbing was used to cleanse wounds and safely disrupt biofilm/bioburdens, post images reflected (-) fluorescence representing negative or below the threshold of the bacteria loads at risk for infection. This imaging helps by giving the provider “real-time” assessment to make medical decisions in the moment to proceed forward with Cellular, Acellular and Matrix-Like Products (CAMPS).

For morbidly obese patients, especially with a BMI>50, simple movements are difficult. The healing rates of pressure injuries/ulcers in patients of this size who are bed bound is challenging due to all of the other factors including Mental Health & patient empowerment and engagement. With the array of other factors that come into play, as an advanced wound company we addressed all possible factors that would aid in her wound healing. The patient’s mental health has improved as well.

Results

After underlying comorbidities and conditions (Standard Wound Care) were addressed with no significant signs of healing, we started advanced modalities, including allograft applications. During her follow-up appointments, we were always discussing her plan of care and some of the best options for her to be involved with managing her chronic wounds. Some of the patient engagement involvements including why she needed to not sit in her chair all day or choosing to even sleep in her wheelchair. This behavior stems from her concerns regarding transferring to her bed, as she fears falling due to her weakened state. In addition, she has expressed financial constraints which have resulted in her inability to afford food until the arrival of her food stamps. The attending home health aide has corroborated this information, acknowledging her own provision of food for the patient in light of her current financial circumstances. Through the efforts of everyone including home care and the caregiver, we were able to provide resources to the patient. These ulcers that had been there for over 5 years, are now 95% healed.

References

  • B Alipoor E, Mehrdadi P, Yaseri M, Hosseinzadeh-Attar MJ. Association of Overweight and Obesity with the Prevalence and Incidence of Pressure Ulcers: A Systemic Review and Meta-Analysis. Clin Nutr. 2021 Sep;40(9):5089-5098. doi: 10.1016/j.clnu.2021.08.006. Epub 2021 Aug 14.PMID: 34455268>
  • B Albury C, Strain WD, Brocq SL, Logue J, Lloyd C, Tahrani A; Language Matters working group. The Importance of language in Engagement between Health-Care Professionals and People Living with Obesity: A Joint Consensus Statement. Lancet Diabetes Endocrinol. 2020 May;8(5):447-455. Doi: 10.1016/S2213 8587(20)30102 9.PMID: 32333880 Review.
  • B Cole, W. Overcoming Social Determinants in Wound Management. Today’s Wound Clinic, April 2023>
  • B Manley S, Mitchell A. The Impact of Nutrition on Pressure Ulcer Healing. Br J Nurs. 2022 Jun 23;31(12):S26-S30. doi: 10.12968/bjon.2022.31.12.S26.PMID: 35736848

Evaluation of Tissue Oxygenation Using Near Infra-red Spectroscopy Following Noncontact,
Low-Frequency Ultrasound (LFU) Therapy

Introduction

Near infra-red spectroscopy (NIRS) has been used to evaluate tissue oxygen saturation and perfusion through the incorporation of Noncontact, Low-Frequency Ultrasound (LFU) Therapy technology. LFU therapy produces a low energy ultrasound-generated mist to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates, and bacteria. This case series presentation demonstrates the effect of LFU therapy on enhancement of tissue oxygenation and perfusion using NIRS.

Methods

NIRS (SnapshotNIR), is a non-invasive imaging device that can measure oxygenated and deoxygenated levels of hemoglobin in the wound and periwound tissues to calculate and create an image of tissue oxygen saturation. Noncontact, Low-Frequency Ultrasound (LFU) Therapy System is an easy-to-use, portable, painless, noncontact, noninvasive, advanced wound care technology that delivers low-frequency ultrasound to the wound. LFU therapy goals are to jump-start the cellular healing process, eliminating barriers to healing by decreasing inflammation, bacteria, and biofilms, while increasing perfusion and vasodilation. This treatment results in a significantly shorter time to wound closure, prevention of reoccurrence, and a substantial reduction in pain. A series of cases is presented to demonstrate the effectiveness of LFU therapy in increasing tissue perfusion oxygenation using SnapshotNIR.

Results

Three subjects received LFU therapy for their wounds/ulcers. LFU therapy was administered using the manufacturers recommended use guidelines. Each subject was treated per the guidelines, then SnapshotNIR imaging was accomplished before and after therapy. LFU acoustic wave therapy promotes healing by controlling inflammation and reducing bacteria in the wound bed while increasing angiogenesis. Further, to promote healing, it increases perfusion through vasodilation, ultimately increasing oxygen and nutrients to the tissue. Increases in tissue oxygenation were measured in the treated wounds/ulcers using NIRS in both subjects.

Discussion

Advanced Adjunctive LFU Therapy specifically targets inflammatory cells, bacteria, biofilms and increased perfusion through vasodilation, to promote healing through angiogenesis and tissue regeneration with limited side effects. This study is the first of many to demonstrate enhancement of tissue oxygenation and perfusion using NIRS imaging following LFU therapy. Additional research is suggested to further define the clinical ramifications of this finding.

References

Captions:

Pt #1 – 87-year-old female, bed bound and unable to turn herself, ongoing deterioration – Pressure Injury Unstageable x3 onset
1/29/24 1st visit 2/13/24 Buttock (unstageable) heel (stage III), back (stage III) (10.44 sq cm). Obtained NIRS images, StO2 >80%, noted total hemoglobin >1 indicating inflammation. Painful with debridement, plans to initiate LFU therapy.

Pt #2 – 68-year-old female with multiple comorbidities diabetes, renal disease
onset September 2023. 10 wounds mixed etiologies (pressure, venous,
diabetes (post TMA). Obtained NIRS images, StO2 <50%, concerns with
microcirculation. Plans to refer out for other testing. Patient is at high risk of
another amputation. Painful with debridement, plans to initiate LFU therapy.

Making a Difference in Patient Engagement & Wound Outcomes with Innovative “Point of Care” Fluorescence Imaging in the Mobile Wound Care Setting.

Introduction

Providing advanced wound healing in the mobile setting (patient’s home) has many challenges of its own. However, over a short period of time this mobile advanced wound care program has evolved in many ways. They have quickly adapted to limited resources, long commutes between patients and early adoption of “Innovative” advanced adjunctive therapies and technologies. This includes incorporating “point of care” bacterial autofluorescence imaging into their patients plan of care. This advanced wound care solution provides “real-time” point-of-care wound imaging for the detection of the presence and location of elevated bacterial loads and digital wound measurement.

Discussion

Improving the providers opportunity to assess and manage in “real-time”. Giving the provider “point of care” diagnostics to assess and manage elevated bacteria loads in the wound/ulcer bed and peri-wound. These results are reflected in their wound healing outcomes in many ways including but not limited to increasing wound / ulcer healing rates, decreasing antibiotic prescribing, decreasing antimicrobial dressing cost, and even preventing readmission rates. Most importantly, improves the patient’s engagement to their plan of care and over all improves their wound healing outcomes.

Methods

Wound care providers have incorporated fluorescence Imaging into their portfolio of innovative technologies to assess and manage patients with elevated bacteria bioburden levels greater than 10.4. Having “real-time” diagnostics allows the providers to make “real-time” decisions for their patients plan of care. By being able to detect the bacterial presence, location and load at point-of-care, it enhances the decision-making plan of care in the moment and improves outcomes.

Results

Retrospective analysis includes over 2200 non-contact real-time fluorescence wound images for bacterial presence, location, and load, per session. Having technology at your fingertips gives the providers the opportunity to manage and/or adjusting patients plan of care, including monitoring for success of Cellular, Acellular and Matrix Like Products (CAMPs). The ability of taking pre and post imaging and videos has allowed the provider to evaluate their plan of care at the bedside, providing them with the opportunity to finesse or complement their original plans of care and optimizing and accelerating healing. Providers are trained to interpret fluorescent images. Red fluorescence signals indicated the presence of Gram- positive and Gram-negative bacteria at loads (above 10.4 colony forming units per gram) and cyan signals (bright white center and a green/blue halo indicates the presence of Pseudomonas Aeruginosa 10.4 DFU. “Real-Time” results to differentiates of red-ranges of fluorescence indicating a variety of unspecified bacteria loads (at >104 CFU/g), or cyan fluorescence specifically identifying Pseudomonas Aeruginosa (at >104 CFU/g). These results give the provider the opportunity to change a plan of care in the moment, which may include additional wound hygiene, and debridement or modifying the treatment orders to include an antimicrobial dressing or even antibiotics if needed. These results immediately provide clinicians with objective information on the presence and location of high bacterial loads to better inform bacterial-infection management strategies. Between opening day of August 2022 until April 2024 our team Fluorescence Imaged over 2,441 wounds.

References

  • Oropallo AR, Andersen C, Abdo R, Hurlow J, Kelso M, Melin M, Serena TE. Guidelines for Point-of-Care Fluorescence Imaging for Detection of Wound Bacterial Burden Based on Delphi Consensus. Diagnostics. 2021; 11(7):1219. https://doi.org/10.3390/diagnostics1107121S
  • Andersen CA, McLeod K, Steffan R. Diagnosis and treatment of the invasive extension of bacteria (cellulitis) from chronic wounds utilizing point-of-care fluorescence imaging. Int Wound J. 2022; 19(5): 996-1008. doi:10.1111/iwj.13693
  • Use of a bacterial fluorescence imaging system to target wound debridement and accelerate healing: a pilot study. Windy Cole and Stacey Coe. Journal of Wound Care 2020 29:Sup7, S44-S52

Captions:

Pt #1 – 77-year-old female, LLE Venous onset date 1/31/21, 1st visit by our providers, 12/5/23 50.22 sq cm, currently over 80% healed standard of care, vascular assessment/management, diagnostic evaluations/intervention & compression management including fluorescence imaging for “real-time” point of care evaluation and management of targeted hygiene and debridement.

Pt #2 – 92-year-old female, fell on knee requiring sutures. Within a few days, the wound reopened on September 1, 2023. 2.3 x 0.7 x 0.4 cm with 0.5 undermining. Standard of Care including management of infection (fluorescence imaging) knee brace. Wound is now 84% healed.

Pt #3 – 59-year-old female, Multiple Sclerosis, recurrent multidrug-resistant UTI, neurogenic bladder with chronic indwelling Foley catheter, underlying ESR and on Hemodialysis. Hx of Osteomyelitis Sacral Pressure Injury stage 4. Onset over a year prior to her 1st visit; onset 1st visit by our providers 4/13/23 15.5 sq cm with 1.5 cm depth and 6.0 cm undermining. Standard of Care including management of infection (fluorescence imaging). Currently wounds are 63%

Going Mobile – Patient Engagement & Satisfaction Improvement with Innovative Portable Technology in the patient’s Home

Introduction

Complex chronic wounds mixed with multiple comorbidities, typically evoke pain and anxiety which make treatment a challenge. This case series examines adjunct modalities in our Advanced Wound Care Mobile Practice (AWCMP) allowing providers to utilize technologies improving patient care and improving healing rates in the patient’s home setting. The novel vibrating wound hygiene system is a mechanical debridement tool (VMDT) which uses low sonic level frequency vibrations to scrub and debride wounds. This tool is battery powered with a reusable hand piece that can be wiped clean. This novel hand-held tool uses vibrational technology in combination with debridement and scrubbing heads and has been used to cleanse wounds, safely disrupt biofilm and necrotic tissue. The purpose of the study was to evaluate this new technology, determining effectiveness for those patients who cannot tolerate traditional debridement methods, or the provider felt it was medically necessary to enhance management of wounds/ ulcers bioburden/necrotic tissue.

Methods

Several patients with different types of chronic wounds managed by our AWCMP in the home setting were evaluated, wound bed status varied from clean to heavily contaminated. Wounds were assessed and cleaned/debrided according to standard protocol. The VMDT replaced/augmented standard methods (curette/scalpel). Images were captured before/after debridement, patients were asked about overall satisfaction and pain. A random sampling of ie. venous, arterial, diabetic ulcers and pressure. Data was collected prospectively, and patients were followed to the end of the trial. Weekly progress was evaluated to include wound measurements, fluorescence imaging, pain scale, and patient satisfaction survey.

Results

Clinically, the VMDT achieved a similar result in cleansing/debridement as traditional methods (scalpel and sharp curettes). However, patient satisfaction/compliance increased along with the pain reduction through vibratory analgesia. Which in turn decreased patient anxiety, depression, and time to debride compared to standard method of debridement. VMDT improved the patients’ engagement with their plan of care.

Discussion

One of the top priorities of wound management is adequate debridement and granulation tissue. Having access to advanced technology in the patient’s home at bedside improves overall satisfaction and time to resolution. The VMDT stimulates microbleeding in the wound bed that jumpstarts healing by cleaning and debriding chronic and contaminated wounds.

Debriding a wound properly and effectively before the final epithelialization stage is crucial for a proper healing outcome. VMDT has been seen to be less painful for the patient, reduces bioburden, and appears to be a more effective alternative to standard debridement methods. Having VMDT available for our AWCMP providers in the mobile setting is one more added tool in their toolbox to manage patient’s painful complex wounds.

References

  • Lammers RL and Smith ZE, Principles of Wound Management, Ch. 34 Clinical Gate Emergency Medicine, 2015.D
  • Manna B, Morrison CA. Wound Debridement. [Updated 2020 Feb 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-.D
  • Gebreyohannes et al, Challenges of intervention, treatment, and antibiotic resistance of biofilm-forming microorganisms, Heliyon 5 (2019).D
  • Stevenson P and Schultz G, The Emerging Science of Biofilm 2019: International Consensus Includes Biofilm Treatment as New Standard of Care, OWM, 2019, Vol 5 (7), July 2019.D World Union of Wound Healing Societies (WUWHS), Florence Congress, Position Document. Management of Biofilm. Wounds International 201
  • Murphy C, Atkin L, Swanson T, Tachi M, Tan YK, Vega de Ceniga M, Weir D, Wolcott R. International consensus document. Defying hard-to-heal wounds with an early antibiofilm intervention strategy: wound hygiene. J Wound ) Care 2020; 29(Suppl 3b): S1–28.D
  • Wolcott RD et al, Biofilm maturity studies indicate sharp debridement opens a time-dependent therapeutic window, JWC Vol 19 (8), 2010: 320 328.D
  • Schultz, G., Bjarnsholt, T., James, G.A., Leaper, D.J., McBain, A.J., Malone, M., Stoodley, P., Swanson, T., Tachi, M., Wolcott, R.D. and (2017), Consensus guidelines for the identification and treatment of biofilms in chronic non healing wounds. Wound Rep and Reg, 2017 (25): 744 757*
  • Murphy C, Atkin L, Vega de Ceniga, weir D, Swanson T. International Consensus document. Embedding Wound hygiene into a proactive; 31: S1 S24

Captions:

Pt #1 – 34-year-old male, had developed in 2020 heart failure, experienced a cardiac arrest and suffered a severe anoxic brain injury. Pressure injuries started in September 2023. Hx of RBKA due Pressure Injury resulting into osteomyelitis. He currently has multiple pressures (buttock, coccyx, gluteal fold, back and left foot 5th digit metatarsal). VMDT was used in combination of standard of care (nutrition, offloading, infection management etc), including selective / surgical
debridement, and NPWT.

Pt #2 – 61-year-old female with PMH of CHF, obesity and chronic wounds (Pressure Injuries/MASD, friction / shear) due to challenges with transferring and caregiver support. Initiated standard of care, lots of patient education and engagement to plan of care.

Pt #3 – 75-year-old female who resides in an ALF, she fell a few months back and injured her LLE, initiated standard wound care including debridement, and utilization of the VMDT device.

Advancing Wound Healing Assessment: The Potential of LFU Therapy Evaluated Through Mobile Multispectral Near-Infrared Spectroscopy

Introduction

Chronic wounds, affecting over 6 million Americans, pose significant challenges and an increased risk of amputations’. Recognizing the societal burden associated with non-healing wounds and their substantial impact on the quality of life for affected individuals, there is a pressing need for advanced modalities in wound management. While conventional protocols succeed in some cases, they often fall short for patients with chronic, non-healing wounds. This study aims to investigate the efficacy of non-contact, non-thermal, low-frequency ultrasound (LFU) therapy by employing mobile multispectral near- infrared spectroscopy (NIRS). The objective is to elucidate the specific pathways through which LFU impacts the healing process, with a focus on documenting and quantifying the wound healing trajectory.

Methods

Using an FDA-cleared handheld mobile multispectral near-infrared imaging device with thermal capabilities*, temperature and tissue oximetry (StO2) were measured pre- and post-treatment using the FDA-cleared LFU device**. The analysis focused on documenting and quantifying the wound healing process.

Results

NIRS imaging revealed disparities in tissue oximetry and temperature following LFU treatment. While LFU therapy promoted healing through vasodilation and the acceleration of angiogenesis, NIRS imaging facilitated the quantification of healing by measuring StO2 levels and visualizing angiogenesis processes.

Discussion:

The utilization of NIRS imaging has the potential to play a crucial role, not just in documenting the effectiveness of LFU treatments, but also in quantifying the healing trajectory across a diverse spectrum of chronic and acute wounds in various patient settings. NIRS has the capability to contribute to the comprehension of LFU treatment’s clinical effectiveness visually demonstrating expedited angiogenesis at the wound site. Recognizing this potential, NIRS could become an indispensable tool for nurse practitioners, enriching their understanding of the healing trajectory. Looking ahead, as our understanding of the mechanisms underlying the efficacy of LFU treatments continues to advance, it is likely to lead to the optimization of parameters and the discovery of novel applications for this technology.

Captions:

Patient #1 – 79-year-old female with ongoing LLE due chronic Vascular (mixed etiologies including lymphedema) Standard Care Initiated, lymphedema pumps, vascular consultant and interventions. NIRS to identify the Sto2 at the tissue wound bed / angiosome and LFUS therapy was initiated due to increasing pain during surgical debridement.

Patient #2 – 88 year old female, LLE Venous / Lymphedema with underlying arterial disease onset over a year ago. She has a recurring infection being managed by her Infectious Disease Physician. LFUS treatments initiated, before and after NIRS showing improvements of StO2 before and after.

References

  • Sen, C. K. et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 17, 763-771 (2009). 
  • Maan, Z. N. et al. Noncontact, low-frequency ultrasound therapy enhances neovascularization and wound healing in diabetic mice. Plast. Reconstr. Surg. 134, 402e-411e (2014). 

* MIMOSA Pro, MIMOSA Diagnostics Inc., Toronto, ON. 

** UltraMIST, SANUWAVE and SANUWAVE Health, Inc., Eden Prairie, MN

Unveiling the Therapeutic Potential of Placental-Derived Grafts Through Mobile Multispectral Near-Infrared Spectroscopy – A Case Series

Introduction

Chronic wounds pose a significant global healthcare challenge, affecting millions of patients and straining resources. Optimal care for intricate surgical wounds, burns, and challenging-to-heal injuries is essential, necessitating advanced and specialized treatments. Placental-derived allografts have been extensively studied for their benefits?. This study explores the potential of skin substitutes using mobile multispectral near-infrared spectroscopy (NIRS), with a focus on the placental extracellular matrix grafts.

Methods

A non-contact, FDA-cleared handheld mobile multispectral near-infrared imaging device with thermal capabilities* was employed for measuring temperature and tissue oximetry (StO2). The case series evaluates the effectiveness of an FDA- cleared skin substitute product**. Patients were longitudinally tracked, and data, including demographics, clinical characteristics, and NIRS findings, were collected and analyzed.

Discussion

Placental-derived grafts signify a groundbreaking advancement in the treatment of acute, traumatic, and challenging wounds. These grafts demonstrate versatility in addressing traumatic lacerations, dehisced incisional wounds, pressure and venous ulcers, post-Mohs surgical wounds, post-surgical incisions, and diabetic ulcers. The integration of NIRS played a critical role in accurately quantifying the healing trajectory, assessing progress, and pinpointing post-application complications of skin substitutes. This pivotal tool provides healthcare professionals with invaluable insights. In summary, this case series underscores the therapeutic potential of placental-derived grafts in wound management, with NIRS acting as a crucial

Results

NIRS imaging offered a comprehensive view of the healing trajectory, capturing variations in tissue oximetry and temperature after applying the skin substitute. It proved to be an efficient method, not only indicating the current state of the wound but also assisting in determining its progress towards normal healing. Thermal imaging added valuable insights, detecting early-stage inflammatory reactions via temperature elevation at the wound site.

Captions:

Pt #1 – 91-year-old female resides in an ALF, she was moving heavy boxes and fell onto the box – he has a LLE trauma wound onset 1/30/24 – 1st visit by HP-2-14, 27 sq cm – standard of care initiated, addressing underlying conditions, fluorescence imaging obtained (-), NIRS imaging obtained 3/20, (80% in wound bed) 3/20, initiated Placental Graft on 4/3.

Pt #2-80-year-old man, developed a Pressure Injury stage 3 after a fall and hip fracture, onset 1/29/24 1st visit by HP 3/8/24, standard of care including Fluorescence Imaging (+ red in the periwound, removed with soaks and debridement) and NIRS greater than 80% Sto2 in the wound bed. Application Graft Readiness.

Pt #3 – 94-year-old female, onset 10/1/23 Left Heel Pressure Injury (9.18 sq cm), 1st visit by HP 1/17/24, all standards of care initiated including Fluorescence Imaging & NIRS. 1st application of a placental-derived graft on 1/31/24 (received a total of 7 applications) 4/3/24 measurements 0.04 sq cm almost healed. instrument for precise monitoring and assessment, thereby contributing valuable insights to the diagnosis and treatment strategies for chronic wounds.

References 

  • Li, S., Mohamedi, A. H., Senkowsky, J., Nair, A. & Tang, L. Imaging in Chronic Wound Diagnostics. Adv. Wound Care 9, 245-263 (2020). 
  • Fairbairn, N. G., Randolph, M. A. & Redmond, R. W. The clinical applications of human amnion in plastic surgery. J. Plast. Reconstr. Aesthet. Surg. 67, 662- 675 (2014).

*MIMOSA Pro; MIMOSA Diagnostics Inc., Toronto, ON. 

**InnovaMatrix, Convatec Triad Life Sciences, Memphis, Tennessee.

Exploring the Therapeutic Potential of Three- Dimensional Decellularized Porcine Liver Grafts Through Mobile Multispectral Near-Infrared Spectroscopy: A Case Series

Introduction

Chronic wounds affect millions of patients worldwide, placing a significant burden on healthcare resources. Addressing the complexities associated with wounds extending to various underlying tissues, including deep, tunneling, and irregular wounds, poses unique challenges. This study aims to explore the therapeutic potential of three-dimensional (3D) grafts as a viable solution for such wounds. This case series explores the potential of skin substitutes using mobile multispectral near-infrared spectroscopy (NIRS), with a focus on the 3D grafts for deep and tunneling wounds.

Methods

An FDA-cleared, handheld mobile multispectral near-infrared imaging device with thermal capabilities* was utilized for measuring temperature and tissue oximetry (StO2) in a non-wound contact manner. The device used in this study also captured digital photographs. This case series assesses the effectiveness of an FDA-cleared skin substitute product** on the healing rate of deep, tunneling, and irregular wounds. Patients were longitudinally tracked to observe the healing trajectory, and relevant data, including demographics, clinical characteristics, and NIRS findings, were collected and analyzed.

Discussion

The success of 3D grafts in deep and irregular wounds, monitored by NIRS, has significant clinical implications. The comprehensive visualization provided by NIRS in monitoring healing trajectories offers invaluable insights for healthcare professionals. Beyond indicating the current state of the wound, NIRS assists in determining whether the wound is progressing toward normal healing. Perfusion parameters correlating with wound depth provide a nuanced understanding of the healing process. However, acknowledging study limitations, future research should explore long-term outcomes, compare graft types, and optimize application timing for deeper insights into 3D graft effectiveness in chronic wound care.

Results

NIRS imaging provided a comprehensive visualization and documentation of the healing trajectory, capturing variations in tissue oximetry and temperature post-skin substitute application. It proved to be an efficient method, not only indicating the current state of the wound but also assisting in determining whether the wound is progressing toward normal healing. Perfusion parameters were correlated with wound depth. Additionally, thermal imaging provided valuable insights, as inflammatory reactions can induce temperature elevation at the wound site.

References 

  • Li, S., Mohamedi, A. H., Senkowsky, J., Nair, A. & Tang, L. Imaging in Chronic Wound Diagnostics. Adv. Wound Care 9, 245-263 (2020). 
  • Mimosa Pro, Mimosa Diagnostics Inc., Toronto, Canada 
  • Miro3D wound matrix, Reprise Biomedical, Inc., Plymouth, MN

Captions:

Pt #1 – 78-year-old female was in a MVA on date 9/1/23 which required nerve repair and a non healing laceration on her arm. Her 1st visit by our provider 1/16/24 10 sq cm using standard of care, monitoring for bacteria loads, moist wound healing. Wound started to show signs of healing however over the next couple of weeks the wound started to deteriorate and now is 12 sq cm. Plans are to start grafting. 

Pt #2 – 51-year-old female, Sacral post surgical 5 cm tumor removed that was attached to her sacrum (partial sacrectomy and total coccygectomy with sphincteroplasty with radiation. 1° visit with our providers 11/29/23 very complex, measures 1.2×0.5×3.2 with tunneling at 7 o’clock position to 4 cm depth. Periwound area is erythematous and edematous. Edema fluctuates due to the nature of radiation history, patient ability to tolerate massage, and manipulation of area and compression. 

Pt #3 – 58-year-old male pressure injury stage 4 49 sq cm with 3 cm depth and undermining. Initiated 3D graft 6 applications it is healing and currently measuring 6.67 sq cm with 0.5cm depth.

Exploring the Potential of Amnion Membrane Allografts via Mobile Multispectral Near-Infrared Spectroscopy: A Case Series

Introduction

Millions of patients globally are impacted by difficult-to-heal wounds, imposing a substantial burden on healthcare resources’. Effectively addressing these wounds is crucial. Skin substitutes emerge as a promising treatment option, providing the necessary structural elements and growth factors for re-epithelialization and revascularization2. Among these substitutes, amnion membrane (dHAM) allografts stand out as particularly promising, intended to repair tissue deficits and expedite healing for chronic and post-surgical wounds. Despite their potential, there is a scarcity of published studies investigating the use of these grafts. This study aims to delve into the potential of skin substitutes, with a specific focus on dHAM allografts, utilizing mobile multispectral near-infrared spectroscopy (NIRS). The primary emphasis is on quantification of dHAM allografts impact on health outcomes.

Methods

Using an FDA-cleared handheld mobile multispectral near-infrared imaging device with thermal capabilities*, measurements of temperature and tissue oximetry (StO2) were performed. This case series evaluates the effectiveness of an FDA-cleared skin substitute product** on the healing rate of chronic non-healing wounds. Patients were longitudinally tracked to observe the healing trajectory, and relevant data, including demographics, clinical characteristics, and NIRS findings, were collected and analyzed.

Results

NIRS imaging provided a comprehensive visualization and documentation of the healing trajectory, capturing variations in tissue oximetry and temperature. The visualization of angiogenesis processes via NIRS imaging provided insights into the intricate mechanisms underlying successful wound closure.

Discussion

The management of difficult-to-heal wounds using dHAM highlights the regenerative potential of medicine in wound care. Mobile NIRS holds promise for assessing wound progression, appraising treatment efficacy, and pinpointing potential complications or impediments to healing. The integration of mobile NIRS imaging in post-application patient monitoring of skin substitutes provides healthcare professionals with invaluable insights. NIRS stands poised to assume a pivotal role in quantifying healing by measuring StO, levels and offering visual insights into the intricate processes of angiogenesis. This case study also underscores the significance of collaborative efforts from a multidisciplinary team, which can significantly improve patient outcomes and enhance their overall quality of life. Nevertheless, further research is imperative to refine optimal practices for managing difficult-to-heal wounds.

Captions:

Pt #1 – 74-year-old gentleman presents with a right forearm trauma/skin tear due to a fall on 1/17/24, 1st visit with HP 2/8/24 minimal – non measurable signs of healing with standard of care. Fluorescence Imaging (-) for bacteria >10.4, & NIRS imaging greater than 80% StO2. Initiated Amnion Membrane Allograft after 5 applications, the patient’s wound is 95% healed.

Pt #2 – 82-year-old male, injured his leg by hitting it on a piece of equipment at the gym. PMH, COPD otherwise good health. LLE trauma wound, standard of care initiated including arterial assessment and edema management. 1st visit 72 sq cm – Fluorescence Imaging (-) for bacteria >10.4, & NIRS imaging greater than 75% StO2. Initiated Amnion Membrane Allograft after 6 applications. Wounds are improving and down to 4.5 sq cm

References 

  • Li, S., Mohamedi, A. H., Senkowsky, J., Nair, A. & Tang, L. Imaging in Chronic Wound Diagnostics. Adv. Wound Care 9, 245-263 (2020). 
  • Bay, C. et al. Comparison of Skin Substitutes for Acute and Chronic Wound Management. Semin. Plast. Surg. 35, 171-180 (2021). 
  • Raza, A. A., Whaley, M. J. & Shakir, M. Management and novel treatment of degloving soft tissue injuries: A case report. Cureus (2023) doi:10.7759/ curous.49999. 

*Mimosa Pro, Mimosa Diagnostics Inc., Toronto, Canada. 

**Membrane Wrap, BioLab Sciences, Scottsdale, AZ.