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临床试验/NCT05137639
NCT05137639已完成不适用

Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting: A Prospective Study With Platelet-rich Fibrin (PRF)

Wuerzburg University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年10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
32
试验地点
1
主要终点
Coverage rate

研究概览

简要总结

Reconstruction of the donor site after radial forearm flap harvesting is a common procedure in maxillofacial plastic surgery. Unfortunately, free skin graft transplantation faces wound healing impairments such as necrosis, (partial) graft loss, or tendon exposure. Several studies have investigated methods to reduce these impairments and demonstrated improvements if the wound bed is optimized. However, these methods are device-dependent, expansive, and time-consuming. Therefore, the application of platelet-rich fibrin (PRF) to the wound bed could be a simple, cost effective, and device-independent method to optimize wound-bed conditions instead. In this study, PRF membranes were applied between the wound bed and skin graft.

详细描述

Reconstruction of the donor site after radial forearm flap harvesting is a common procedure in maxillofacial plastic surgery. It is normally carried out with split-thickness or full-thickness free skin grafts. Unfortunately, free skin graft transplantation faces wound healing impairments such as necrosis, (partial) graft loss, or tendon exposure. Several studies have investigated methods to reduce these impairments and demonstrated improvements if the wound bed is optimized, for example through negative pressure wound therapy or vacuum-assisted closure. However, these methods are device-dependent, expansive, and time-consuming. Therefore, the application of platelet-rich fibrin (PRF) to the wound bed could be a simple, cost effective, and device-independent method to optimize wound-bed conditions instead. In this study, PRF membranes were applied between the wound bed and skin graft. Growth factor release could stimulate fibroblast migration, wound healing and angiogenesis. Further more PRF act as a lubricant layer to protect skin graft from tendon motion. This could improve graft in-growth.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •>18 years, donor site on the forearm after radial forearm flap surgery, free skin graft reconstruction of this skin defect, informed consent

排除标准

  • •<18 years, inclusion criteria were not met

研究组 & 干预措施

non-PRF group

No Intervention

Standard surgical procedure (free skin grafting to reconstruct donor sites without PRF).

PRF group

Experimental

Participants received platelet-rich fibrin (PRF) prior to free skin grafting

干预措施: Platelet-rich fibrin (PRF) (Procedure)

结局指标

主要结局

Coverage rate

时间窗: 10-14 days

The coverage rate was measured 10-14 days after surgery with a photo analysis

次要结局

  • Evaluation Score (ES)(10-14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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