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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Procedure: Platelet-rich fibrin (PRF)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Würzburg, Bavaria, Germany, 97070
      • University Hospital of Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF group; Participants received platelet-rich fibrin (PRF) prior to free skin grafting	Procedure: Platelet-rich fibrin (PRF); PRF was only applied in the experimental arm to improve wound bed conditions
No Intervention: non-PRF group; Standard surgical procedure (free skin grafting to reconstruct donor sites without PRF).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coverage rate	The coverage rate was measured 10-14 days after surgery with a photo analysis	10-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation Score (ES)	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.	10-14 days

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Principal Investigator: Anton Straub, MD, Dep. of Oral and Maxillofacial Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 143/20-me

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No