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

NCT ID: NCT02712164

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-07-31

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.

Conditions

Split-thickness Skin Graft Donor Sites; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Modified NPWT dressing

Intervention Type: DEVICE

Use of negative pressure wound therapy on split-thickness skin graft (STSG) donor sites

Tegaderm

Intervention Type: DEVICE

Standard of care for STSG donor sites.

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.

Group Type: ACTIVE_COMPARATOR

Tegaderm

Intervention Type: DEVICE

Standard of care for STSG donor sites.

Interventions

Modified NPWT dressing

Use of negative pressure wound therapy on split-thickness skin graft (STSG) donor sites

Intervention Type: DEVICE

Tegaderm

Standard of care for STSG donor sites.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Indranil Sinha

Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 9523602 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24251839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25294112 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26774601 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23141686 (View on PubMed)

Other Identifiers

2016P000030

Identifier Type: -

Identifier Source: org_study_id