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

Mass General Brigham

Status: Withdrawn

Conditions: Burns; Split-thickness Skin Graft Donor Sites

Treatments: Device: Tegaderm; Device: Modified NPWT dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02712164

2016P000030

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental: Modified NPWT dressing

Experimental group

Description:

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.

Treatment:

Device: Modified NPWT dressing

Device: Tegaderm

Control: Tegaderm

Active Comparator group

Description:

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.

Treatment:

Device: Tegaderm