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

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.

Study Overview

• Status: Withdrawn
• Conditions: Burns; Split-thickness Skin Graft Donor Sites
• Intervention / Treatment: Device: Modified NPWT dressing; Device: Tegaderm

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Modified NPWT dressing; In the experimental group, a microporous silver-impregnated foam with a thin silicone contact layer (Mepilex Ag) will be applied. A macroporous foam layer (V.A.C. GranuFoam) and an occlusive dressing (V.A.C. Drape) will then be applied to cover the foam, plus 3-5cm border of intact skin. The occlusive dressing will then be pinched and a 2cm hole will be cut to apply the SensaT.R.A.C. Pad that supplies pressure from the NPWT unit. NPWT will be applied at 125mmHg throughout treatment using KCI's InfoV.A.C. Therapy Unit. The donor site dressing will be replaced on postoperative day 5-7 and a new occlusive dressing (Tegaderm) will be applied.	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.
Active Comparator: Control: Tegaderm; In the control group, the donor sites will be dressed with an occlusive dressing only (Tegaderm). The donor site dressings will be replaced on postoperative day 5-7 and a new occlusive dressing (Tegaderm) will be applied.	Device: Tegaderm; Standard of care for STSG donor sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as measured by visual analog scale (VAS).		Assessed up to 14 days
Wound healing rate (re-epithelialization)	Evaluated by the investigator and by a blinded expert using photographs.	Assessed up to 1 month
Wound exudate: mRNA expression	Wound exudate and tissue lysate will be subjected to polymerase chain reaction (PCR) for semi-quantitative analysis of mRNA expression.	Assessed up to 14 days
Wound exudate: protein content	Quantitative enzyme-linked immunosorbent assay (ELISA) will allow analysis of target protein content.	Assessed up to 14 days
Tissue sample: re-epithelialization and granulation percentage	Tissue samples will be fixed and processed for hematoxylin and eosin (H&E) staining and analyzed microscopically for re-epithelialization percentage.	Assessed up to 14 days
Tissue sample: epidermal thickness	Tissue samples will be fixed and processed for hematoxylin and eosin (H&E) staining and analyzed microscopically for epidermal thickness.	Assessed up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Quality	As measured by the Vancouver scar scale (VAS)	Assessed up to 1 month postoperatively

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: dressing; NPWT; donor site; Split-thickness skin graft; STSG; negative-pressure wound therapy
• Other Study ID Numbers: 2016P000030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No