International Wound Journal

<jats:title>ABSTRACT</jats:title><jats:p>Venous leg ulcers (VLUs) are traditionally managed with standard‐of‐care dressings, compression and appropriate adjunctive venous interventions for pathologic venous reflux. Due to pathophysiological complexity and underlying patient comorbidities, conducting randomised controlled trials to evaluate the comparative efficacy of advanced treatment modalities is difficult, as many patients would likely be excluded. This retrospective, pragmatic, real‐world evidence (RWE) study compared the healing outcomes of VLUs treated with either ovine forestomach matrix (OFM) (<jats:italic>n</jats:italic> = 312) or collagen/oxidised regenerated cellulose (ORC) (<jats:italic>n</jats:italic> = 239) in outpatient wound care centres. Unlike restrictive randomised controlled trials, minimal inclusion and exclusion criteria were applied to create two treatment cohorts that reflected the general VLU population. The incidence (%) of closure was greater in OFM‐treated VLUs at 12, 24 and 36 weeks, and this difference was significant at 24 and 36 weeks compared to collagen/ORC. Median time to wound closure was significantly faster (<jats:italic>p</jats:italic> = 0.045) in the OFM cohort (11.1 ± 0.6 weeks) compared to the collagen/ORC group (12.3 ± 1.0 weeks). Cox proportional hazards analysis demonstrated that OFM‐treated VLUs had a significantly greater probability of healing (up to ~40%). This RWE comparative efficacy study further substantiates the clinical benefit of OFM in the treatment of chronic wounds, such as VLU, in a real‐world patient cohort.</jats:p>

publication_history

received

accepted

published

Venous Leg Ulcers

BMJ Clinical Evidence

Venous Ulcers: Diagnosis and Treatment

American Family Physician

Wound Cleansing for Treating Venous Leg Ulcers

Cochrane Database of Systematic Reviews

Hydrogel Dressings for Venous Leg Ulcers

Therapeutic Ultrasound for Venous Leg Ulcers

Debridement for Venous Leg Ulcers

Assessing the Application and Effectiveness of Human Amniotic Membrane in the Management of Venous and Diabetic Ulcers: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Cureus

A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers

Wounds

Use of an Advanced Extracellular Matrix Dressing in the Treatment of Acute and Chronic Wounds: A Malaysian Case Series

Wounds Asia

Use of an Ovine Collagen Dressing With Intact Extracellular Matrix to Improve Wound Closure Times and Reduce Expenditures in a US Military Veteran Hospital Outpatient Wound Center

Surgical Technology International

Use of Ovine‐Based Collagen Extracellular Matrix and Gentian Violet/Methylene Blue Antibacterial Foam Dressings to Help Improve Clinical Outcomes in Lower Extremity Wounds: A Retrospective Cohort Study

Proactive and Early Aggressive Wound Management: A Shift in Strategy Developed by a Consensus Panel Examining the Current Science, Prevention, and Management of Acute and Chronic Wounds

In‐Vivo Evaluation of a Reinforced Ovine Biologic for Plastic and Reconstructive Procedures in a Non‐Human Primate Model of Soft Tissue Repair

Eplasty

Venous leg ulcers (VLUs) are traditionally managed with standard-of-care dressings, compression and appropriate adjunctive venous interventions for pathologic venous reflux. Due to pathophysiological complexity and underlying patient comorbidities, conducting randomised controlled trials to evaluate the comparative efficacy of advanced treatment modalities is difficult, as many patients would likely be excluded. This retrospective, pragmatic, real-world evidence (RWE) study compared the healing outcomes of VLUs treated with either ovine forestomach matrix (OFM) (n = 312) or collagen/oxidised regenerated cellulose (ORC) (n = 239) in outpatient wound care centres. Unlike restrictive randomised controlled trials, minimal inclusion and exclusion criteria were applied to create two treatment cohorts that reflected the general VLU population. The incidence (%) of closure was greater in OFM-treated VLUs at 12, 24 and 36 weeks, and this difference was significant at 24 and 36 weeks compared to collagen/ORC. Median time to wound closure was significantly faster (p = 0.045) in the OFM cohort (11.1 ± 0.6 weeks) compared to the collagen/ORC group (12.3 ± 1.0 weeks). Cox proportional hazards analysis demonstrated that OFM-treated VLUs had a significantly greater probability of healing (up to ~40%). This RWE comparative efficacy study further substantiates the clinical benefit of OFM in the treatment of chronic wounds, such as VLU, in a real-world patient cohort.

Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real-World Evidence Study.

Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real‐World Evidence Study

<jats:title>Abstract</jats:title><jats:p>We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first‐in‐human study, this was a prospective, open‐label, multi‐centre, dose escalation study across five dose cohorts and involving a total of 43 patients treated three times weekly for up to 4 weeks (12 applications). The primary and secondary endpoints of the study were to assess the systemic safety, local tolerability, and early proof of concept both for wound debridement and healing. Results indicated that the tarumase enzyme was well tolerated when applied topically to wounds, with no indications of systemic absorption, no evidence of antibody generation, and no systemic effects on coagulation pathways. Locally, there was no evidence of pain on application, no local itching, no increases in erythema, oedema, exudate or bleeding and only a few treatment emergent adverse events were reported. As the concentration of tarumase was escalated, trends towards faster and improved effectiveness of wound debridement were observed, especially in patients with significant slough at baseline. Trends towards faster rates of healing were also noted based on observations of increased granulation tissue, increased linear healing and reduction in surface area over the 4‐week treatment period.</jats:p>

Permissive maintenance debridement—the role of enzymatic debridement in chronic wound care

Wounds Int

Parameter for measurement of wound closure

We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first-in-human study, this was a prospective, open-label, multi-centre, dose escalation study across five dose cohorts and involving a total of 43 patients treated three times weekly for up to 4 weeks (12 applications). The primary and secondary endpoints of the study were to assess the systemic safety, local tolerability, and early proof of concept both for wound debridement and healing. Results indicated that the tarumase enzyme was well tolerated when applied topically to wounds, with no indications of systemic absorption, no evidence of antibody generation, and no systemic effects on coagulation pathways. Locally, there was no evidence of pain on application, no local itching, no increases in erythema, oedema, exudate or bleeding and only a few treatment emergent adverse events were reported. As the concentration of tarumase was escalated, trends towards faster and improved effectiveness of wound debridement were observed, especially in patients with significant slough at baseline. Trends towards faster rates of healing were also noted based on observations of increased granulation tissue, increased linear healing and reduction in surface area over the 4-week treatment period.

First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers.

First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers

Advances in Skin &amp; Wound Care

<jats:title>ABSTRACT</jats:title>
          <jats:sec>
            <jats:title>OBJECTIVE</jats:title>
            <jats:p>To review the literature to determine whether compression therapies and nutrition status influence venous ulcer healing.</jats:p>
          </jats:sec>
          <jats:sec>
            <jats:title>DATA SOURCE</jats:title>
            <jats:p>A systematized bibliographic review was carried out by searching PubMed, Scopus, and Cochrane databases for studies published between 2015 and 2020, using descriptors in Spanish and English.</jats:p>
          </jats:sec>
          <jats:sec>
            <jats:title>STUDY SELECTION</jats:title>
            <jats:p>After establishing the research question and applying the filters based on inclusion and exclusion criteria, 114 articles were found. After screening, 11 articles were selected for the review: 8 were identified in the literature search, and 3 were added from the bibliographic references of other studies.</jats:p>
          </jats:sec>
          <jats:sec>
            <jats:title>DATA EXTRACTION</jats:title>
            <jats:p>The authors developed a data extraction sheet that recorded the following variables: author, country, year of publication, level of evidence, research design, therapy type, initial ulcer size, active ulcer history, pain, healed wounds, wound reduction, therapy tolerance, nutrition assessment method, body mass index, and nutrition disorders.</jats:p>
          </jats:sec>
          <jats:sec>
            <jats:title>DATA SYNTHESIS</jats:title>
            <jats:p>Four studies analyzed the relationship between nutrition status and venous ulcer healing, finding that these patients tend to have a high body mass index; a deficit of nutrients such as vitamin A, D, or zinc; and an excess of lipids and carbohydrates. Seven studies compared different types of compression to determine which provided the best results, with two- and four-layer therapy being the most commonly used. Variables such as small wound size and recent onset were associated with better prognosis.</jats:p>
          </jats:sec>
          <jats:sec>
            <jats:title>CONCLUSIONS</jats:title>
            <jats:p>In terms of nutrition, the parameters analyzed are very limited. Although several studies show that two-layer therapy produces the greatest ulcer healing, there is not enough information to recommend one type of therapy over the other. Therefore, more clinical trials are needed to study broader nutrition parameters and compare the types of therapy under matched conditions to determine their influence on ulcer healing.</jats:p>
          </jats:sec>

Why venous leg ulcers have difficulty healing: overview on pathophysiology, clinical consequences, and treatment

J Clin Med

What’s new: management of venous leg ulcers: approach to venous leg ulcers

J Am Acad Dermatol

Prevalence and clinical characteristics of chronic venous disease in patients seen in primary care in Spain: results of the international study Vein Consult Program

Cir Esp

Overview of guidelines for the prevention and treatment of venous leg ulcers: a US perspective

J Multidiscip Healthc

Venous ulcers: diagnosis and treatment

Am Fam Physician

Effects and associations of nutrition in patients with venous leg ulcers: a systematic review

J Adv Nurs

Nutrition in wound care management: a comprehensive overview

Vitamin D and skin repair: a prospective, double-blind and placebo controlled study in the healing of leg ulcers

Rev Col Bras Cir

Vitamin D deficiency in patients with chronic venous ulcers

Factors associated with poor healing and recurrence of venous ulceration

Plast Reconstr Surg

Nutritional support in the treatment and prevention of pressure ulcers: an overview of studies with an arginine enriched oral nutritional supplement

J Tissue Viability

Nutritional status and food intake in nine patients with chronic low-limb ulcers and pressure ulcers: importance of oral supplements

Nutrition

Understanding the role of nutrition and wound healing

Nutr Clin Pract

PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation

Ann Intern Med

Hierarchy of evidence: levels of evidence and grades of recommendation from current use [in Spanish]

Rev Chilena Infectol

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous Leg Ulcer Study IV, VenUS IV): a randomised controlled trial

Lancet

A comparative clinical study on five types of compression therapy in patients with venous leg ulcers

Int J Med Sci

Adjustable compression wrap devices are cheaper and more effective than inelastic bandages for venous leg ulcer healing. A multicentric Italian randomized clinical experience

Phlebology

Efficacy of two compression systems in the management of VLUs: results of a European RCT

J Wound Care

Clinical superiority of an innovative two-component compression system versus four-component compression system in treatment of active venous leg ulcers: a randomized trial

Clinical outcomes and cost-effectiveness of three different compression systems in newly-diagnosed venous leg ulcers in the UK

Nutrition status in patients with wounds: a cross-sectional analysis of 50 patients with chronic leg ulcers or acute wounds

Eur J Dermatol

Anthropometric, biochemical, and food consumption parameters are associated with venous leg ulcer area and duration

Adv Skin Wound Care

Nutritional profile of older adults with chronic venous leg ulcers: a pilot study

Geriatr Nurs

The effectiveness of a four-layer compression bandage system in comparison with class 3 compression hosiery on healing and quality of life in patients with venous leg ulcers: a randomised controlled trial

Int Wound J

The effectiveness of a specialised oral nutrition supplement on outcomes in patients with chronic wounds: a pragmatic randomised study

J Hum Nutr Diet

The role of nutrition for pressure injury prevention and healing: the 2019 international clinical practice guideline recommendations

Tratamiento nutricional en ulceras por presión y ulceras venosas

Rev Chi Nutr

Body mass index and outcomes in critically injured blunt trauma patients: weighing the impact

J Am Coll Surg

Patients with chronic leg ulcers show diminished levels of vitamins A and E, carotenes, and zinc

Dermatol Surg

Compression bandages or stockings versus no compression for treating venous leg ulcers

Cochrane Database Syst Rev

To review the literature to determine whether compression therapies and nutrition status influence venous ulcer healing.
A systematized bibliographic review was carried out by searching PubMed, Scopus, and Cochrane databases for studies published between 2015 and 2020, using descriptors in Spanish and English.
After establishing the research question and applying the filters based on inclusion and exclusion criteria, 114 articles were found. After screening, 11 articles were selected for the review: 8 were identified in the literature search, and 3 were added from the bibliographic references of other studies.
The authors developed a data extraction sheet that recorded the following variables: author, country, year of publication, level of evidence, research design, therapy type, initial ulcer size, active ulcer history, pain, healed wounds, wound reduction, therapy tolerance, nutrition assessment method, body mass index, and nutrition disorders.
Four studies analyzed the relationship between nutrition status and venous ulcer healing, finding that these patients tend to have a high body mass index; a deficit of nutrients such as vitamin A, D, or zinc; and an excess of lipids and carbohydrates. Seven studies compared different types of compression to determine which provided the best results, with two- and four-layer therapy being the most commonly used. Variables such as small wound size and recent onset were associated with better prognosis.
In terms of nutrition, the parameters analyzed are very limited. Although several studies show that two-layer therapy produces the greatest ulcer healing, there is not enough information to recommend one type of therapy over the other. Therefore, more clinical trials are needed to study broader nutrition parameters and compare the types of therapy under matched conditions to determine their influence on ulcer healing.

Influence of Nutrition Status and Compression Therapy on Venous Ulcer Healing: A Systematic Review.

Influence of Nutrition Status and Compression Therapy on Venous Ulcer Healing: A Systematic Review

Papers