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临床试验/NCT07074223
NCT07074223已完成不适用

Deep Fascial Graft Versus Acellular Dermal Matrix Conduit on Repaired Hand's Flexor Tendon: A Comparative Study

Aswan University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Number of participant with treatment related limitation of Movement

研究概览

简要总结

The investigators aim to evaluate the efficacy & applicability of using deep fascial grafts and acellular dermal matrix conduits in reducing post flexor tendon repair adhesions and improving the clinical outcome.

研究设计

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

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •recent hand cut tendon

排除标准

  • •All patients less than 16 years old.
  • •Zone 1 , 3 , 4 and zone 5 flexor tendon injuries.
  • •Patients with flexor pollicis longus tendon injury.
  • •Severely lacerated or crushed tendons.
  • •Tendon defects.
  • •Multiple level tendon injuries.
  • •Associated injuries to muscles.
  • •Associated hand or forearm fractures.
  • •Patients with poor general condition.
  • •Patients with limited passive hand movements.
  • •Soft tissues defects overlying the repaired tendons.

研究组 & 干预措施

Control Group

Placebo Comparator

Modefied kestler tendon repair

干预措施: Modified Kestler tendon repair (Procedure)

Pelnac Group

Experimental

Modified kestler tendon repair wrapped by Pelnac

干预措施: ADM (Pelnac) wrapping of repaired tendon (Procedure)

Fascia Group

Experimental

modefied kestler tendon repair wrapped by fascial graft

干预措施: Fascial wrapping the site of tendon repair (Procedure)

结局指标

主要结局

Number of participant with treatment related limitation of Movement

时间窗: 6 months postoperative

Buck-Gramcko II criteria

Number of participant who have fibrous adhesions in Ultra sonography

时间窗: 6 months poostoperative

muscloskeletal ultrasonography

次要结局

未报告次要终点

研究者

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

Osama Hassan Elbanna

lecturer of plastic surgery

Aswan University

研究点 (1)

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