Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting

October 27, 2013 updated by: Yongqian Bian, Tang-Du Hospital
Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.

Study Overview

Detailed Description

Background:Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.

Methods: 192 consecutive patients undergoing split-thickness skin grafting were included in the study and the participants were randomly divided into three groups: Group A was regrafted with thin STSG, while, Group B and Group C were covered with the occlusive hydrocellular dressing and paraffin gauze, respectively. The three groups were compared regarding to the time of epithelialization, pain sensed by the patients and the scar formation.

Study Type

Observational

Enrollment (Actual)

192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 56 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study cohort included 192 participants, who were randomly selected from patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University.

Description

Inclusion Criteria:

  • patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University

Exclusion Criteria:

  • The patients who were significant psychiatric, hypersensitive to silver, and not be followed up were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the treatment group A
The people in treatment group were regrafted with thin split-thickness skin graft
Group A (the treatment group) were regrafted with thin split-thickness skin graft
the control group B
The group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith & Nephew)
group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith & Nephew)
the control group C
Group C were covered with paraffin gauze
Group C covered with paraffin gauze

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time of epithelialization
Time Frame: up to 4 weeks
The time of epithelialization was observed every 3 days
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain sensed by the patients
Time Frame: up to 6 months
Pain sensed by the patients was assessed by Wong-Baker FACES Pain Rating Scale on day 2 and 5 after surgery
up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar formation of skin donor site
Time Frame: 1 year
Scar formation of skin donor sites was evaluated by Vancouver scar scale in terms of colour, vascular distribution, thickness and scratchability 6-12 months after surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yongqian Bian, doctor, specify unaffiliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

October 27, 2013

First Posted (ESTIMATE)

November 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 27, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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