The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05571904
Collaborator
(none)
40
1
2
7.3
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: thick STSG; thin STSG
N/A

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
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.(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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft in the Reconstruction of the Donor Site
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: the thick STSG group

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).

Procedure: thick STSG; thin STSG
For all the patients, thick STSGs (at a depth of 0.7 mm) were harvested from the upper lateral thighs to repair skin defects at functional sites or joint sites. For patients in the thick STSG group, the surgeons harvested a larger size of thick STSGs than the size of recipient sites. The size of the donor site was 150% - 200% of the size of the recipient site. Part of the thick STSG was grafted onto the recipient site. Subsequently, the leftover skin was punctured (in 1.5:1 mesh ratio) and stretched to obtain expansion. The donor site was covered by the leftover skin completely. In other words, the donor site was reconstructed by resurfacing the large sheet of thick STSG in situ. For patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with a large sheet of thin STSGs (at a depth of 0.4 mm) which were harvested from other parts of the patients.

Active Comparator: the thin STSG group

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.

Procedure: thick STSG; thin STSG
For all the patients, thick STSGs (at a depth of 0.7 mm) were harvested from the upper lateral thighs to repair skin defects at functional sites or joint sites. For patients in the thick STSG group, the surgeons harvested a larger size of thick STSGs than the size of recipient sites. The size of the donor site was 150% - 200% of the size of the recipient site. Part of the thick STSG was grafted onto the recipient site. Subsequently, the leftover skin was punctured (in 1.5:1 mesh ratio) and stretched to obtain expansion. The donor site was covered by the leftover skin completely. In other words, the donor site was reconstructed by resurfacing the large sheet of thick STSG in situ. For patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with a large sheet of thin STSGs (at a depth of 0.4 mm) which were harvested from other parts of the patients.

Outcome Measures

Primary Outcome Measures

  1. healing time of the donor sites [2 months post surgery]

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

Secondary Outcome Measures

  1. life quality (36-item short form health survey scores) [Prior to surgery or at 6 months post-surgery]

    The life quality of patients was evaluated by the 36-item short form health survey (SF-36) scores (including General Health scores, Mental Health scores, Social Function scores, and Vitality scores). The minimum value is 0. The maximum value is 100. The higher score means a better outcome.

  2. pains scores (Visual Analogue Scales) [on Day 1 and Day 7 postoperatively]

    The degrees of pain at the donor sites were evaluated by the Visual Analogue Scales. Patients were asked to score levels of pain (0 = no pain, 5 = worst pain) using Visual Analogue Scales. The higher score means a worse outcome.

  3. pruritus scores [at 3 months and at 6 months post-surgery]

    The degrees of pruritus at the donor sites were measured by scores (1 = never or occasional itches, 2 = itches do not disturb sleep, 3= itches disturb sleep). The higher score means a worse outcome.

  4. scars scores ( Vancouver Scar Scales ) [at 3 months and 6 months post-surgery]

    The scar formation at the donor sites were evaluated with the Vancouver Scar Scales (from 0 to 15, 0 = best and 15 = worst) in terms of pigmentation, vascularity, pliability and height. The higher score means a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanjing First Hospital Nanjing Jiangsu China 210029

Sponsors and Collaborators

  • Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Director: Rong Wu, phD, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
YinWu, attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05571904
Other Study ID Numbers:
  • KY20220701-08
First Posted:
Oct 7, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by YinWu, attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital, Nanjing First Hospital, Nanjing Medical University

Study Results

No Results Posted as of Oct 13, 2022