NCT02712164

Molecular, Histologic, and Clinical Analysis of Negative Pressure Wound Therapy (NPWT) for Split-thickness Skin Graft (STSG) Donor Sites

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Split-thickness Skin Graft Donor Sites
• Burns

Interventions

Type	Name	Description
DEVICE	Modified NPWT dressing	Use of negative pressure wound therapy on split-thickness skin graft (STSG) donor sites
DEVICE	Tegaderm	Standard of care for STSG donor sites.

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-03-18
• Last updated: 2017-06-06