Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Procedure: Platelet-rich fibrin (PRF)

• Registration Number: NCT05137639
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-11-30
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

• <18 years, inclusion criteria were not met

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF group	Platelet-rich fibrin (PRF)	Participants received platelet-rich fibrin (PRF) prior to free skin grafting

Primary Outcome Measures

Name	Time	Method
Coverage rate	10-14 days	The coverage rate was measured 10-14 days after surgery with a photo analysis

Secondary Outcome Measures

Name	Time	Method
Evaluation Score (ES)	10-14 days	ES included surgical complications (infection, graft loss..) and was obtained 10-14 days after surgery. Minimum value: 0, maximum value 6. A higher score indicates a worse surgical outcome.

Trial Locations

Locations (1)

University Hospital of Würzburg; 🇩🇪 Würzburg, Bavaria, Germany