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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Reconstruction
• Intervention / Treatment: Procedure: thick STSG; thin STSG

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yin Wu, phD; Phone Number: 18305155832; Email: medwuyin@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Nanjing First Hospital
      • Contact: Yin Wu, phD; Phone Number: 18305155832; Email: medwuyin@163.com
      • Contact: Chao Hao, MD; Phone Number: 15905166117; Email: haochao@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing time of the donor sites	The complete healing time of the donor sites was defined as the day when 100% epithelialization was achieved,	2 months post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Pubmed

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 10, 2022

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: reconstruction; donor site; thick split-thickness skin graft; thin split-thickness skin graft
• Other Study ID Numbers: KY20220701-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study protocol, Iinformed Consent Form will be shared on the website:http://www.stats.gov.cn/tjsj/
• IPD Sharing Time Frame: December,31,2023
• IPD Sharing Access Criteria: no limits
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No