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Clinical Trials/NCT05571904
NCT05571904
Recruiting
Not Applicable

The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft in the Reconstruction of the Donor Site

Nanjing First Hospital, Nanjing Medical University1 site in 1 country40 target enrollmentStarted: May 1, 2022Last updated:
ConditionsReconstruction

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
healing time of the donor sites

Overview

Brief Summary

In clinical settings, split-thickness skin graft (STSG) remain the gold standard for covering large skin defects. However, STSGs usually bring complications to the donor sites. The study objective was to compare the efficacy of thick split-thickness skin graft versus thin split-thickness skin graft in the reconstruction of the donor site.

Detailed Description

All patients were randomly divided into two groups. For the patients in the thick STSG group, the surgeons harvested thick STSGs which were larger than recipient sites. The extra skin was punctured and stretched to cover the donor site (the novel technique). For the patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with thin STSGs which were harvested from other parts of the patients. The 36-item short form health survey (SF-36) scores, pain scores, pruritus scores, scar scores and rates of complications were compared between the two groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients had skin defects at functional sites or joint sites.
  • Patients aged 20-80 years.
  • The lateral thighs were chosen as the donor sites.

Exclusion Criteria

  • Patients who were unable to complete the follow-up.
  • Pregnant or nursing mothers were not included.
  • Patients had an alternative source of pain other than surgical sites.
  • Patients with organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or cancers.
  • Patients with autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
  • Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.
  • Other reasons.

Outcomes

Primary Outcomes

healing time of the donor sites

Time Frame: 2 months post surgery

The complete healing time of the donor sites was defined as the day when 100% epithelialization was achieved,

Secondary Outcomes

  • pains scores (Visual Analogue Scales)(on Day 1 and Day 7 postoperatively)
  • pruritus scores(at 3 months and at 6 months post-surgery)
  • scars scores ( Vancouver Scar Scales )(at 3 months and 6 months post-surgery)
  • life quality (36-item short form health survey scores)(Prior to surgery or at 6 months post-surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

YinWu

attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital

Nanjing First Hospital, Nanjing Medical University

Study Sites (1)

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