Consensus recommendations for optimizing the use of intact fish skin graft in the management of acute and chronic lower extremity wounds.

BACKGROUND: Since 2017, the clinical use of IFSG has increased substantially in the United States, with some use in Europe and Asia as well. However, scant consensus data have been published on such use. OBJECTIVE: The authors sought to develop consensus recommendations for the clinical use of IFSG in the management of acute and chronic LEWs. METHODS: A panel of 8 expert clinicians in the United States used a 2-cycle NFG process to develop consensus statements based on their own clinical practice and the literature. At their initial meeting in October 2021, panel members discussed the management of DFUs, VLUs, atypical LEWs, and traumatic LEWs in their practices. Consensus statements were drafted, voted on, and rated by relative importance. At the second meeting in October 2022, the panel discussed the initial survey results; a second survey was conducted, and panel members revised the recommendations and indicated the relative importance of each in the final report. A systematic literature review of English-language articles published from January 2016 through November 2022 was conducted as well, using the search terms: "fish skin," "piscine graft," "fish tissue," "intact fish skin graft," "Cod skin," "Omega 3 fatty acid graft." RESULTS: Forty-three statements were generated and grouped into 5 sections comprising general recommendations for LEWs and recommendations specific to DFUs, VLUs, atypical LEWs, and traumatic LEWs. The primary general recommendation is the need to determine wound etiology based on clinical evaluation and reviewing related test results. For DFUs and VLUs, the main recommendations are to adhere to first-line therapy (ie, standard of care, follow conventional guidelines [multilayer compression therapy], offloading, and assessment of wound perfusion) before introducing IFSG. CONCLUSIONS: Publications on and clinical experience in the use of IFSGs have increased substantially in the past several years. The 43 consensus recommendations are meant to guide physicians in the optimal use of IFSG in the management of acute and chronic LEWs.

Use of negative pressure wound therapy for the treatment of venous leg ulcers.

NPWT has probably been the most important addition to wound care in the current century. Despite this fact, its use in the treatment of VLUs remains very limited. This review first examines the documented and potential VLU wound environment changes that can be facilitated by NPWT. The data supporting the use of NPWT for VLU wound bed preparation, the management of fluid drainage, and the bolstering of skin grafts are evaluated. The similarities and differences between suNPWT, traditional NPWT, and NPWTi are outlined. Included in this review is when and where each therapy may have a place in the treatment of VLUs. Finally, a brief algorithm to enhance the use of NPWT in the treatment of VLUs is presented.

Final efficacy and cost analysis of a fish skin graft vs standard of care in the management of chronic diabetic foot ulcers: a prospective, multicenter, randomized controlled clinical trial.

INTRODUCTION: DFUs remain a cause of significant morbidity. OBJECTIVE: This is the third of 3 planned articles reporting on a prospective, multicenter, randomized controlled trial evaluating the use of omega-3-rich acellular FSG compared with CAT in the management of DFUs. MATERIALS AND METHODS: A total of 102 patients with a DFU (n = 51 FSG, n = 51 CAT) participated in the trial as ITT candidates, with 77 of those patients included in the PP analysis (n = 43 FSG, n = 34 CAT). Six months after treatment, patients with healed ulcers were followed up for ulcer recurrence. A cost analysis model was applied in both treatment groups. RESULTS: The proportion of closed wounds at 12 weeks was compared, as were the secondary outcomes of healing rate and mean PAR. Diabetic foot wounds treated with FSG were significantly more likely to achieve closure than those managed with CAT (ITT: 56.9% vs 31.4%; P =.0163). The mean PAR at 12 weeks was 86.3% for FSG vs 64.0% for CAT (P =.0282). CONCLUSIONS: Treatment of DFUs with FSG resulted in significantly more wounds healed and an annualized cost savings of $2818 compared with CAT.

Topical autologous blood clot therapy: consensus panel recommendations to guide use in the treatment of complex wound types.

The etiology of acute and chronic wounds goes beyond those often reported in the literature, including those with exposed structures, those in which the entire wound bed cannot be visualized, and patients who are not candidates for typical standard of care. Treatment options for these patients may be limited. TABCT is a viable option for these complex wound types and is not hindered by logistical, procedural, or patient factors. A consensus panel of providers with extensive experience in treatment of these wound types was convened to develop consensus recommendations on the use of TABCT in specific complex wound types. Four consensus statements were defined for TABCT use in patients who cannot undergo sharp or extensive debridement, as a protective barrier to prevent further bacterial ingress, in patients with wounds in which the entire wound bed cannot be safely visualized, and in wounds with exposed tendon and/or bone. Consensus panel recommendations show that TABCT application assists in maintenance of a moist wound healing environment, autolytic debridement, recruitment and delivery of factors essential for wound healing, prevention of pathogen entry, and ability to completely fill wound voids that cannot be fully visualized. Additional advantages of TABCT use are its cost-effectiveness, ease of access, minimal related complications, and proven clinical efficacy.

Topical autologous blood clot therapy: an introduction and development of consensus panel to guide use in the treatment of complex wound types.

Complex or hard-to-heal wounds can be acute or chronic; the complexity is based on patient-specific local, systemic, and psychosocial factors. Use of autologous tissue can be a significant adjunct to wound closure. Grafts and flaps are the most common autologous tissue used in wound reconstruction. However, patient factors, wound size, and exposed structures may preclude using these methods as primary or even secondary closure techniques. Alternative autologous tissue therapies include those derived from adipose, epidermis or dermis, bone marrow, and blood. Limitations of these treatment modalities include access-related difficulty, cost, creation of a secondary donor site, use of singular or limited cell types, and sparse or contradictory evidence basis of their efficacy of use. A panel of providers experienced in wound care and surgical wound management was convened to create a series of publications on the use of topical autologous blood clot therapy (TABCT) in the treatment of complex wounds. This publication, the first in a series, provides an evidence basis of the gap between definition and treatment of complex wounds, an overview of the use of autologous therapies in these wounds, and the science behind TABCT. The development of a consensus panel for decision pathways and recommendations for TABCT use in specific complex wound types are also discussed. Subsequent articles will provide consensus recommendations on the use of TABCT in full-thickness wounds with exposed tendon and/or bone and undermining or tunneling wounds, in wounds in patients who are nonsurgical candidates, in those who cannot undergo sharp debridement, in patients with arterial wounds who have been maximally revascularized, and in those with transsphincteric anal fistula. This article provides a foundation of knowledge and describes the plan for consensus panel decision pathways and recommendation development of use of TABCT in the treatment of specific complex wound types.

Evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers: penultimate analysis of a multicenter, prospective, randomized controlled trial.

OBJECTIVE: This is the second of 3 planned articles reporting on a prospective, multicenter, randomized controlled trial assessing the efficacy of fish skin graft in the management of diabetic foot ulcers in comparison with the standard of care (collagen alginate dressing). MATERIALS AND METHODS: The primary end point of this prospective randomized trial is the number of closed wounds at 12 weeks. RESULTS: As of the time of this writing, 94 patients had completed the protocol. At 12-week follow-up, healing was achieved in 63.0% of index ulcers (29 of 46 patients) in the acellular fish skin graft group compared with 31.3% in the control group (15 of 48 patients) (P =.0036). In both groups, the mean time to healing was 7 weeks. The median number of applications of the fish skin graft to achieve healing was 6. CONCLUSION: A clinically and statistically significant difference in healing was observed between patients treated with acellular fish skin graft and those treated with a collagen alginate dressing. The data support the completion of this prospective randomized trial.

The use of fetal bovine collagen on chronic wounds increases limb salvage: a single-center retrospective analysis.

OBJECTIVE: As part of a quality assurance project at a large tertiary care surgical program in New York City, the effect of debridement, negative pressure wound therapy, and cellular- and tissue-based products (CTPs) on limb salvage was evaluated based on the following outcomes: freedom from amputation, wound closure, and freedom from readmission. Fetal bovine collagen was among the CTPs evaluated. MATERIALS AND METHODS: The data used in this study were derived from a database of all patients who had undergone procedures involving placement of a dermal matrix at the center over a 2.5-year period (January 2016-June 2018). This retrospective analysis included 256 patients who underwent debridement and/or placement of a CTP as part of the treatment course for chronic wounds. RESULTS: Of the 252 patients identified, 34 required either minor or major all-cause amputation from the initial wound intervention, whereas for 218 patients, there were no recorded amputations through the end of the study period after the initial wound intervention. When fetal bovine collagen was evaluated as an explanatory variable to the presence of future amputation, a statistically significant relationship between the variables was found. CONCLUSIONS: The results of the current data analysis indicate that a treatment algorithm that includes appropriate antibiotic therapy, tangential hydrosurgery, application of fetal bovine collagen, and a short course of negative pressure wound therapy may be a more favorable option to achieve limb salvage, freedom from readmission, and wound closure.

The role of internal offloading and rotational flap closure of charcot arthropathy-related midfoot ulcers

Open foot wounds resulting from diabetic Charcot foot are very problematic to treat secondary to the anatomic abnormalities as well as the profound neuropathy associated with this condition. With these complexities in mind, most prospective trials, to some degree, exclude these patients from inclusion. Total contact casting and tissue-based therapy, including skin grafts, can be helpful in closing these wounds. However, rapid recurrence is very common. The authors present one technique to help alleviate the pressure point(s) and provide more adequate coverage for these problematic wounds.

Venous leg ulcers: potential algorithms of care.

Management of VLUs can be challenging, depending on wound complexity, and may require the use of several treatment modalities to achieve complete wound closure or significant wound area reduction. This review presents a systematic approach to management of VLUs based on previous literature and the authors' clinical experience, with consideration given to wound size, etiology, and responses to prior treatment. Techniques described include debridement (autolytic, enzymatic, sharp/surgical), compression therapy, physical therapy, medical adjuncts, and cellular- and tissue-based therapy. The algorithm of care for VLUs is multimodal. Appropriate diagnostic studies must be performed, including venous duplex and appropriate pathophysiology to confirm the diagnosis of VLU. After the correct diagnosis is confirmed, appropriate treatment may commence. All patients should undergo appropriate wound debridement; the exact modality used is dependent on wound characteristics. Patients must also adhere to consistent compression therapy. Any underlying venous disease that is amenable to surgical intervention should be addressed. Treatment with a medical adjunct and physical therapy are recommended. For patients who do not achieve significant wound area reduction, the addition of CTP is recommended. Use of these methods should result in substantial wound area reduction and/or wound closure.

A Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Omega-3-Rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers.

INTRODUCTION: Omega-3-rich fish skin grafts have been shown to accelerate wound healing in full-thickness wounds. OBJECTIVE: The goal of this study was to compare the fish skin graft with standard of care (SOC) using collagen alginate dressing in the management of treatment-resistant diabetic foot ulcers (DFUs), defined as superficial ulcers not involving tendon capsule or bone. MATERIALS AND METHODS: Patients with DFUs who were first treated with SOC (offloading, appropriate debridement, and moist wound care) for a 2-week screening period were then randomized to either receiving SOC alone or SOC plus fish skin graft applied weekly for up to 12 weeks. The primary endpoint was the percentage of wounds closed at 12 weeks. RESULTS: Forty-nine patients were included in the final analysis. At 12 weeks, 16 of 24 patients' DFUs (67%) in the fish skin arm were completely closed, compared with 8 of 25 patients' DFUs (32%) in the SOC arm (P value = .0152 [N = 49]; significant at P < .047). At 6 weeks, the percentage area reduction was 41.2% in the SOC arm and 72.8% in the fish skin arm. CONCLUSIONS: The application of fish skin graft to previously nonresponsive DFUs resulted in significantly more fully healed wounds at 12 weeks than SOC alone. The study findings support the use of fish skin graft for chronic DFUs that do not heal with comprehensive SOC treatment.

Hydrosurgical Debridement Use Associated With Decreased Surgical Site-Related Readmissions: A Retrospective Analysis.

INTRODUCTION: Debridement is the cornerstone of wound care management. It allows for the removal of fibrinous and necrotic debris from the wound bed as well as the reduction of bacterial bioburden, thus allowing for proper granulation and wound healing. Hydrosurgical debridement uses a controlled, high-pressure fluid jet to cut and remove necrotic debris, contaminants, and bacteria, thereby facilitating a potentially more aggressive debridement. OBJECTIVE: The efficacy of this system was compared with that of other methods of debridement in reducing readmissions due to surgical site infections (SSIs). MATERIALS AND METHODS: Two Current Procedural Terminology codes were used to identify 289 unique patients treated for lower extremity wounds. All patients were treated at a vascular surgery service in a large tertiary care wound program from January 2016 to June 2018. Chart review on wound management was performed. A total of 190 of the 289 patients underwent wound debridement over the course of treatment. Logistic regression was calculated with subsequent SSI admission as the dependent variable. RESULTS: On assessing readmissions owing to SSI following debridement, use of hydrosurgical debridement was found to be associated with decreased SSI admissions (odds ratio, 0.31; 95% CI, 0.142-0.677; P < .05). This finding was compared with the results of either standard sharp soft tissue excisional debridement or the use of pulse irrigation. CONCLUSIONS: There are multiple options to consider when formulating an approach for wound management, including the method of debridement used. One goal of debridement is to decrease the bacterial bioburden in the wound bed to both encourage better wound healing and decrease the rate of wound infections. The present study found that the use of hydrosurgical debridement was associated with decreased SSI readmissions, which could potentially result in better wound care for the patient and possibly decreased health care costs because of a lower rate of readmissions. Further investigation of these 2 potential outcomes is necessary.

A Standardized Approach to Evaluating Lower Extremity Chronic Wounds Using a Checklist.

As the population ages and more people live with diabetes, obesity, and vascular disease, chronic wounds have become more prevalent. Increasingly, wound care falls into the hands of clinicians who may be new to the specialty. To facilitate a better understanding of wounds and to ensure all integral items for best outcomes are considered, an interprofessional panel of wound care experts developed a checklist to aid in lower extremity wound identification, assessment, evaluation, and potential complication recognition. This checklist focuses on an evidence-based approach to obtaining a medical history, evaluating the wound, determining the etiology, and assessing perfusion, edema, infection, and neurologic status. The goal of this fundamental evaluation tool is to help the clinician move towards the next steps in optimizing patient care. Evidence-based support for each item on the checklist is reviewed and detailed for clinician reference.

Clostridial Collagenase for the Management of Diabetic Foot Ulcers: Results of Four Randomized Controlled Trials.

BACKGROUND: Despite major treatment advances, diabetic foot ulcers (DFUs) remain a frequent and debilitating complication of diabetes mellitus and a major cause of significant morbidity and mortality. OBJECTIVE: This study evaluates and compares clinical effectiveness of clostridial collagenase ointment (CCO) with standard care (SC) in patients with DFUs, with the goal to define best clinical criteria under which to use CCO in the DFU population. MATERIALS AND METHODS: This is a pooled data analysis of 4 randomized controlled trials that compared clinical effectiveness of CCO to SC. A total of 174 adult patients with 1 target DFU each who underwent treatment with CCO (n = 88) or SC (n = 86) for 4 or 6 weeks were evaluated. Assessments included wound area reduction, wound bed status, and time to closure. RESULTS: Statistically significant mean percentage change in wound area from baseline was numerically greater for CCO than SC at the end of study (EOS) following 6 or 8 weeks of treatment; these values were -56% and -10%, respectively, in the subgroup of plantar surface ulcers (P = .05) and wounds assessed as "low necrosis" (≤ 25% necrotic) at baseline (-64% vs. -20%). When rapidly healing ulcers were excluded from the analysis, the difference in ulcer area reduction was even greater for CCO compared with SC at EOS (-53% vs. -7%; P = .05). CONCLUSIONS: Active CCO therapy was associated with a nonstatistically greater reduction in wound size than any of the passive or mechanical SC modalities at end of treatment. This was statistically significant when used in conjunction with sharp debridement and for slow healing ulcers, larger sized wounds, or plantar surface wounds.

Management of Chronic Wounds: Diagnosis, Preparation, Treatment, and Follow-up.

Management of chronic wounds remains challenging in terms of prevalence and complexity. Considerable progress has been made in understanding the science of wound healing during the past decade, sparking volumes of publications and the development of hundreds of dressing and therapy options. There is a need for a simpli ed overview of evidence-based criteria to assist in the accurate diagnosis and appropriate management of chronic wounds in all care settings. An expert panel of 11 wound healing specialists experienced in various care settings convened to discuss best practices and recommended guidelines for managing major chronic wound types. Prior to the meeting, panel members reviewed 8 preselected peer-reviewed articles and 1 white paper containing treatment algorithms for all major chronic wound types. During the meeting, each panelist presented current evidence-based guidelines regarding a specific chronic wound type and case studies to illustrate concepts in the guidelines. This publication is a result of the panel discussion and presents an overview of literature- and experience- based criteria to help guide chronic wound diagnosis, assessment, treatment, and follow-up. A cycle of steps is presented as a framework to guide holistic care for all patients with chronic wounds, including de- hisced surgical wounds, diabetic foot ulcers, venous leg ulcers, arterial insu ciency ulcers, and pressure ulcers/injuries. Emphasis is placed on criteria to assist accurate diagnosis and dressing/therapy selection, holistic elements of patient and wound bed preparation, interventions to achieve patient adherence to a care plan, and follow-up to help prevent wound recurrence.

Effect of Negative Pressure Wound Therapy With Instillation on Bioburden in Chronically Infected Wounds.

INTRODUCTION: Standard negative pressure wound therapy (NPWT) has been shown to help close wounds despite increasing planktonic bioburden. Both planktonic and biofilm critical colonization are associated with delayed wound healing; therefore, reducing microbial colonization is thought to aid wound healing. The use of NPWT with topical antimicrobial irrigation solution has previously shown reduction in quantitative planktonic bioburden when combined with sharp debridement in chronic wounds. OBJECTIVE: The goal of this study was to evaluate the effectiveness of NPWT with instillation (NPWTi) on biofilm of chronic wounds. MATERIALS AND METHODS: A prospective, randomized trial was conducted. Following sharp debridement, 20 patients with chronic wounds were randomized to 1 week of either NPWTi with 0.125% sodium hypochlorite solution (n = 10) or NPWT without instillation (n = 10). Serial wound biopsy was performed predebridement, postdebridement, and after 1 week of study therapy to test for quantitative nonplanktonic or biofilm-protected bacteria. RESULTS: As expected, there was no difference in change in wound size between the 2 groups at 1 week. The NPWTi group had a mean reduction in quantitative biofilm-protected bacteria of 48%, while the NPWT without instillation group had a mean increase of 14% (P < .05). DISCUSSION: Consistent with previous studies, this trial demonstrates that NPWTi with dilute sodium hypochlorite solution is effective at reducing nonplanktonic bioburden of chronically, critically colonized wounds. CONCLUSION: Therefore, based on this and previously published work, this therapy provides both planktonic and nonplanktonic bioburden reduction as well as NPWT benefits and may be a tool for the preparation of infected wound beds prior to definitive closure.

Negative Pressure Wound Therapy With Instillation: Review of Evidence and Recommendations.

Negative pressure wound therapy with instillation (NPWTi) and dwell time is an adjunctive treatment modality for selected complex wounds. Because of the greater amount of research now available, a multidisciplinary expert panel comprising the fields of podiatry, plastic and general surgery, burn treatment, infectious diseases, and orthopedics was convened on July 11, 2015, to produce a summary of the data and recommendations on the use of NPWTi. The panel members each reviewed available published literature on NPWTi in the PubMed, Cochrane, and Google Scholar databases from 1 January 2012 up until 20 July 2015 using the string search term negative pressure wound therapy instillation provided by the panel moderator; there were no restrictions on the language or type of publication. Panel members discussed their experiences and worked to reach consensus on several predefined topics. NPWTi was found to be most appropriate for properly selected complex hosts or wounds such as patients with multiple comorbidities, patients with an American Society of Anesthesiology Classification ≥ 2, severe traumatic wounds, diabetic foot infections, and wounds complicated by invasive infection or extensive biofilm. NPWTi should not be used routinely to treat simple wounds or hosts without comorbidities.There is evidence that when NPWTi is added to standard of care in properly selected cases it provides better overall clinical outcomes than standard of care alone, even when including NPWT. Based on published evidence and panel member experience, the Panel recommends a dwell time - fluid briefly instilled into the wound and allowed to diffuse for a user-specified time - of 10-20 minutes followed by 2-4 hours of negative pressure at -125 mmHg, although larger wounds may need times of up to 6 hours. Normal saline (0.9%) is the preferred solution for NPWTi, except in special situations. NPWTi with dwell time is an adjunct to other standard principles of appropriate wound assessment and treatment (e.g., debridement, pressure offloading, systemic antibiotic therapy, vascular assessment and revascularization when needed, or glycemic control).

Office based therapies for complex lower extremity epithelial defects.

The chronic wound environment and the ideal way in which to regenerate healthy tissue remain enigmas in the field of wound healing. There are multiple modalities that have been evaluated in an attempt to discern the most clinically beneficial and cost-effective treatment strategies for the millions of individuals who suffer from chronic wounds and their associated morbidity. Engineered skin substitutes represent one of the novel and continuously evolving approaches to providing wound coverage and regenerating functional skin. Herein we describe a number of the products available and the literature to date on their use and efficacy. We will close with a discussion of the cost-reimbursement structure for these products, which is currently undergoing an important shift.

Update 2012: Regenerative Medicine in Wounds: Current Use of Growth Factors, Cell Therapy, and Negative Pressure Wound Therapy for Chronic Wounds.

While we move toward the brink of being able to regenerate or replace human cells, tissues, or organs to restore or establish normal function, we are not there yet. The techniques that are available and being brought to bear on the field of chronic wounds include: growth factors, gene therapy, stem cell transplantation, tissue engineering, and reprogramming cell and tissue types. We review the biomedical techniques from bench to animal to human application. The clinical approaches from what has been tried in clinical growth factor application to the injection of stem cells or progenitor cells directly into a wound (cell therapy) are also reviewed. In addition, newly opening trials in topical cell therapy, injectable stem cell therapy, and topical autologous growth factor are addressed. Although tissue engineering is a very significant portion of regenerative medicine, it has recently been addressed well by other authors. We focus on why we are spending less time on specific growth factor therapy and more resources on cellular therapy. Finally, we address where negative pressure wound therapy fits into regenerative medicine.

Endovascular interventions for limb salvage.

 Although operative bypass is still considered the "gold stan- dard" for treating peripheral arterial disease, over the last decade en- dovascular interventions have become more popular and now represent the vast majority of peripheral arterial treatments being performed. Open bypass is associated with an unacceptable morbidity and mor- tality that is not encountered to the same extent with endovascular techniques. However, outcomes of endovascular intervention are de- pendent upon the location and nature of the lesion, as well as possibly the technologies available to treat the lesion and the experience of the interventionalist. In correctly selected patients, endovascular tech- niques should be the primary management employed for critical limb ischemia. The group of patients that would benefit from endovascular techniques continues to expand with new data constantly emerging. This article will review the current endovascular techniques currently being employed, focusing on the indication for specific intervention. .

Bacterial burden and wound outcomes as influenced by negative pressure wound therapy .

UNLABELLED:  Abstract: Negative pressure wound therapy (NPWT) has consistently shown significant clinical benefits in wound healing, but the mechanisms are not fully elucidated. While a reduction in bacterial burden is one possible contributor, studies have shown mixed results in this regard. The present study used a porcine infected wound model to test the effect of NPWT on bacterial burden. METHODS: Infected wounds (Pseudomonas aeruginosa, coagulase negative Staphylococcus, and Bacteroides fragilis) in a porcine model were treated with V.A.C.® therapy with the standard GranuFoam™ dressing, V.A.C. therapy with the GranuFoam Silver® dressing, or moist gauze for a period of 7 days with three dressing changes. Quantitative and semiquantitative bacterial cultures, histological samples, and digital photographs were taken at dressing changes. RESULTS: The wounds continued to show gross and microscopic improvement when treated with standard NPWT and NPWT with silver compared to moist wound care controls. However, the bacterial burden in all wounds continued to increase and broadened to include local skin flora, which had been absent immediately after wounding. These increases in bacteria were not affected by the use of silver dressings. CONCLUSION: Negative pressure wound therapy with either standard NPWT foam or silver NPWT foam produced significant improvements in local wound appearance. This occurred despite a persistently high level of bacterial infection; thus, the improvement in healing of these infected wounds cannot be explained by a change in the bacterial burden. .