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临床试验/NCT05571904
NCT05571904招募中不适用

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 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
healing time of the donor sites

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

healing time of the donor sites

时间窗: 2 months post surgery

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YinWu

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

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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