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

NCT02712164 | Withdrawn DMC

• 1 other identifier: 2016P000030
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Split-thickness Skin Graft Donor Sites; Burns

Keywords

Split-thickness skin graft; STSG; donor site; negative-pressure wound therapy; NPWT; dressing

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Wound Healing Quality

  Assessed up to 1 month postoperatively

Study Arms (2)

Experimental: Modified NPWT dressing

EXPERIMENTAL

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; Device: Tegaderm

Control: Tegaderm

ACTIVE COMPARATOR

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

Interventions

Modified NPWT dressing DEVICE

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

Experimental: Modified NPWT dressing

Tegaderm DEVICE

Standard of care for STSG donor sites.

Control: Tegaderm; Experimental: Modified NPWT dressing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (5)

• 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.

  PMID: 9523602 BACKGROUND

• 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.

  PMID: 24251839 BACKGROUND

• 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.

  PMID: 25294112 BACKGROUND

• 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.

  PMID: 26774601 BACKGROUND

• 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.

  PMID: 23141686 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 18, 2016
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 6, 2017

Record last verified: 2017-06