Molecular, Histologic, and Clinical Analysis of Negative Pressure Wound Therapy (NPWT) for Split-thickness Skin Graft (STSG) Donor Sites
- Conditions
- BurnsSplit-thickness Skin Graft Donor Sites
- Registration Number
- NCT02712164
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
The purpose of this single-center, randomized, prospective cohort study is to evaluate the clinical outcome and negative-pressure wound therapy (NPWT) mediated modulation of the biologic milieu of a modified NPWT dressing on split-thickness skin graft (STSG) donor sites.
- Detailed Description
The investigators have designed a prospective randomized trial in which subjects will be assigned to a modified negative-pressure wound therapy (NPWT) dressing or standard moist dressing. The investigators will measure the percentage of re-epithelization at set postoperative time intervals using digital photography, pain using the visual analog scale (VAS), and healing quality using the Vancouver Scar Scale (VSS). The investigators hypothesize that the NPWT will lead to less pain and increased re-epithelization in a shorter postoperative time course. This specific aim seeks to prove/disprove that patients who receive a modified NPWT dressing perceive the advantage with improved healing, pain, shorter length of stay, and other wound symptoms related to delayed donor site wound healing.
The donor site for STSGs provides a consistent model of superficial wounds that offers the opportunity to study both mechanisms of wound healing and potential mechanisms of action of NPWT. In patients undergoing both standard dressings and NPWT, the investigators will sample the wound exudate and perform microbiopsies of the healing wound at fixed intervals and perform histologic and molecular analysis in order to quantify the degree of re-epithelization and the trophic and inflammatory profile of the healing wound.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age 18-60
- Both genders are eligible for study
- Written consent obtained from the subject or agent
- Donor site wounds must not exceed 5% total body surface area (TBSA)
- Subject must be receiving a split-thickness skin graft (STSG)
- Donor site is amenable to either NPWT or standard of care (occlusive dressing)
- Ability to comply with necessary wound care/follow up
- Age <18 years
- Subject has been diagnosed with Diabetes
- Subject is a smoker
- Subject takes steroids
- Subject takes immunosuppressive medications
- Subject with immunosuppressive disorders
- Donor site wounds that exceed 5% total body surface area (TBSA)
- Subject has sensitivity to silver or acrylic adhesives
- Inability to comply with necessary wound care/follow up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Tissue sample: re-epithelialization and granulation percentage Assessed up to 14 days Tissue samples will be fixed and processed for hematoxylin and eosin (H\&E) staining and analyzed microscopically for re-epithelialization percentage.
Tissue sample: epidermal thickness Assessed up to 14 days Tissue samples will be fixed and processed for hematoxylin and eosin (H\&E) staining and analyzed microscopically for epidermal thickness.
Wound exudate: mRNA expression Assessed up to 14 days Wound exudate and tissue lysate will be subjected to polymerase chain reaction (PCR) for semi-quantitative analysis of mRNA expression.
Wound healing rate (re-epithelialization) Assessed up to 1 month Evaluated by the investigator and by a blinded expert using photographs.
Wound exudate: protein content Assessed up to 14 days Quantitative enzyme-linked immunosorbent assay (ELISA) will allow analysis of target protein content.
Pain as measured by visual analog scale (VAS). Assessed up to 14 days
- Secondary Outcome Measures
Name Time Method Wound Healing Quality Assessed up to 1 month postoperatively As measured by the Vancouver scar scale (VAS)