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

NCT01974583 | Completed DMC

• 1 other identifier: TDLL-2030130
• Study Type: observational
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Skin Graft Disorder; Disorder of Skin Donor Site; Wound Healing Disturbance of

Keywords

the split-thickness skin graft （STSG） donor site; regraft; wound healing

Outcome Measures

Primary Outcomes (1)

• The time of epithelialization

  The time of epithelialization was observed every 3 days

  up to 4 weeks

Secondary Outcomes (1)

• Pain sensed by the patients

  up to 6 months

Other Outcomes (1)

• Scar formation of skin donor site

  1 year

Study Arms (3)

the treatment group A

The people in treatment group were regrafted with thin split-thickness skin graft

Procedure: regrafted with thin split-thickness skin graft

the control group B

The group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith \& Nephew)

Procedure: covered with the occlusive hydrocellular dressing

the control group C

Group C were covered with paraffin gauze

Procedure: covered with paraffin gauze

Interventions

regrafted with thin split-thickness skin graft PROCEDURE

Group A (the treatment group) were regrafted with thin split-thickness skin graft

the treatment group A

covered with the occlusive hydrocellular dressing PROCEDURE

group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith \& Nephew)

the control group B

covered with paraffin gauze PROCEDURE

Group C covered with paraffin gauze

the control group C

Eligibility Criteria

• Age: 5 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Officials

• Yongqian Bian, doctor

  specify Unaffiliated

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr Yongqian Bian

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: November 1, 2013
• Study Start: January 1, 2002
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2013
• Last Updated: November 1, 2013

Record last verified: 2013-10