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Split-thickness Skin Graft Donor SitesNCT02712164

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

A study testing Modified NPWT dressing and Tegaderm in people with Split-thickness Skin Graft Donor Sites and Burns, run by Brigham and Women's Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Split-thickness Skin Graft Donor Sites, Burns
What is being tested?
Modified NPWT dressing and Tegaderm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2017to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Age <18 years
  • Subject has been diagnosed with Diabetes
  • Subject is a smoker
  • Subject takes steroids
  • Subject takes immunosuppressive medications
  • Subject with immunosuppressive disorders
Show all 9Show fewer
  • 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.

About this study

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.

Read the 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.

Being tested
Modified NPWT dressing, Tegaderm
Keywords
Split-thickness skin graft, STSG, donor site, negative-pressure wound therapy, NPWT, dressing
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified NPWT dressingDevice

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

  • TegadermDevice

    Standard of care for STSG donor sites.

Study groups in NCT02712164
Study groupRoleWhat they receive
Experimental: Modified NPWT dressingExperimentalIn 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.
Receives: Device: Modified NPWT dressing; Device: Tegaderm
Control: TegadermActive comparatorIn 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.
Receives: Device: Tegaderm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain as measured by visual analog scale (VAS).

    Measured: Assessed up to 14 days

  2. Wound healing rate (re-epithelialization)

    Evaluated by the investigator and by a blinded expert using photographs.

    Measured: Assessed up to 1 month

  3. Wound exudate: mRNA expression

    Wound exudate and tissue lysate will be subjected to polymerase chain reaction (PCR) for semi-quantitative analysis of mRNA expression.

    Measured: Assessed up to 14 days

  4. Wound exudate: protein content

    Quantitative enzyme-linked immunosorbent assay (ELISA) will allow analysis of target protein content.

    Measured: Assessed up to 14 days

  5. 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.

    Measured: Assessed up to 14 days

  6. Tissue sample: epidermal thickness

    Tissue samples will be fixed and processed for hematoxylin and eosin (H\&E) staining and analyzed microscopically for epidermal thickness.

    Measured: Assessed up to 14 days

Secondary outcomes (1)

  1. Wound Healing Quality

    As measured by the Vancouver scar scale (VAS)

    Measured: Assessed up to 1 month postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2016 (estimated)
  2. Study startJul 2017 (estimated)
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Why it stopped: Lack of resources.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02712164
Sponsor's protocol ID
2016P000030
Status last verified
Jun 2017
First submitted
29 Feb 2016
Last updated
6 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 9523602

  • 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.

    PubMed 24251839

  • 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.

    PubMed 25294112

  • 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.

    PubMed 26774601

  • 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.

    PubMed 23141686

Questions about this trial

What is this clinical trial studying?

A study testing Modified NPWT dressing and Tegaderm in people with Split-thickness Skin Graft Donor Sites and Burns, run by Brigham and Women's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain as measured by visual analog scale (VAS). (time frame: Assessed up to 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02712164, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.

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