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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02712164
• Other study ID #: 2016P000030
• Status: Withdrawn
• Phase: N/A
• First received: February 29, 2016
• Last updated: June 5, 2017
• Start date: July 2017
• Est. completion date: July 2018

Study information

• Verified date: June 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Split-thickness Skin Graft Donor Sites

Intervention

Device:
• Modified NPWT dressing
Use of negative pressure wound therapy on split-thickness skin graft (STSG) donor sites
• Tegaderm
Standard of care for STSG donor sites.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View Citation

Orgill DP, Bayer LR. Negative pressure wound therapy: past, present and future. Int Wound J. 2013 Dec;10 Suppl 1:15-9. doi: 10.1111/iwj.12170. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured by visual analog scale (VAS).		Assessed up to 14 days
Primary	Wound healing rate (re-epithelialization)	Evaluated by the investigator and by a blinded expert using photographs.	Assessed up to 1 month
Primary	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
Primary	Wound exudate: protein content	Quantitative enzyme-linked immunosorbent assay (ELISA) will allow analysis of target protein content.	Assessed up to 14 days
Primary	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
Primary	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	Wound Healing Quality	As measured by the Vancouver scar scale (VAS)	Assessed up to 1 month postoperatively