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

Wound Healing Disturbance of Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974583
• Other study ID #: TDLL-2030130
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: October 27, 2013
• Start date: January 2002
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 56 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Disorder of Skin Donor Site
• Skin Diseases
• Skin Graft Disorder
• Wound Healing Disturbance of

Intervention

Procedure:
• regrafted with thin split-thickness skin graft
Group A (the treatment group) were regrafted with thin split-thickness skin graft
• covered with the occlusive hydrocellular dressing
group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith & Nephew)
• covered with paraffin gauze
Group C covered with paraffin gauze

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scar formation of skin donor site	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	Yes
Primary	The time of epithelialization	The time of epithelialization was observed every 3 days	up to 4 weeks	Yes
Secondary	Pain sensed by the patients	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	Yes