Clinical trial NCT02712164: Molecular, Histologic, and Clinical Analysis of Negative Pressure Wound Therapy (NPWT) for Split-thickness Skin Graft (STSG) Donor Sites
Official title: Molecular, Histologic, and Clinical Analysis of Negative Pressure Wound Therapy (NPWT) for Split-thickness Skin Graft (STSG) Donor Sites
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Split-thickness Skin Graft Donor Sites
Burns
Keywords: Split-thickness skin graft
STSG
donor site
negative-pressure wound therapy
NPWT
dressing
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain as measured by visual analog scale (VAS).
timeFrame: Assessed up to 14 days
measure: Wound healing rate (re-epithelialization)
timeFrame: Assessed up to 1 month
measure: Wound exudate: mRNA expression
timeFrame: Assessed up to 14 days
measure: Wound exudate: protein content
timeFrame: Assessed up to 14 days
measure: Tissue sample: re-epithelialization and granulation percentage
timeFrame: Assessed up to 14 days
measure: Tissue sample: epidermal thickness
timeFrame: Assessed up to 14 days
Secondary outcomes:
measure: Wound Healing Quality
timeFrame: Assessed up to 1 month postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: Genecov DG, Schneider AM, Morykwas MJ, Parker D, White WL, Argenta LC. A controlled subatmospheric pressure dressing increases the rate of skin graft donor site reepithelialization. Ann Plast Surg. 1998 Mar;40(3):219-25. doi: 10.1097/00000637-199803000-00004.
citation: Orgill DP, Bayer LR. Negative pressure wound therapy: past, present and future. Int Wound J. 2013 Dec;10 Suppl 1(Suppl 1):15-9. doi: 10.1111/iwj.12170.
citation: Glass GE, Murphy GF, Esmaeili A, Lai LM, Nanchahal J. Systematic review of molecular mechanism of action of negative-pressure wound therapy. Br J Surg. 2014 Dec;101(13):1627-36. doi: 10.1002/bjs.9636. Epub 2014 Oct 8.
citation: Fischer S, Wall J, Pomahac B, Riviello R, Halvorson EG. Extra-large negative pressure wound therapy dressings for burns - Initial experience with technique, fluid management, and outcomes. Burns. 2016 Mar;42(2):457-65. doi: 10.1016/j.burns.2015.08.034. Epub 2016 Jan 13.
citation: Nuutila K, Siltanen A, Peura M, Harjula A, Nieminen T, Vuola J, Kankuri E, Aarnio P. Gene expression profiling of negative-pressure-treated skin graft donor site wounds. Burns. 2013 Jun;39(4):687-93. doi: 10.1016/j.burns.2012.09.014. Epub 2012 Nov 8.