Clinical trial NCT05571904: The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft
Official title: The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft in the Reconstruction of the Donor Site
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reconstruction
Keywords: donor site
thick split-thickness skin graft
thin split-thickness skin graft
reconstruction
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: (1) Patients had skin defects at functional sites or joint sites; (2) Patients aged 20-80 years; (3) The lateral thighs were chosen as the donor sites.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: healing time of the donor sites
timeFrame: 2 months post surgery
Secondary outcomes:
measure: life quality (36-item short form health survey scores)
timeFrame: Prior to surgery or at 6 months post-surgery
measure: pains scores (Visual Analogue Scales)
timeFrame: on Day 1 and Day 7 postoperatively
measure: pruritus scores
timeFrame: at 3 months and at 6 months post-surgery
measure: scars scores ( Vancouver Scar Scales )
timeFrame: at 3 months and 6 months post-surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Rong Wu, phD
role: STUDY_DIRECTOR
References:
citation: Bian Y, Sun C, Zhang X, Li Y, Li W, Lv X, Li J, Jiang L, Li J, Feng J, Li XY. Wound-healing improvement by resurfacing split-thickness skin donor sites with thin split-thickness grafting. Burns. 2016 Feb;42(1):123-130. doi: 10.1016/j.burns.2015.07.008. Epub 2015 Nov 23.