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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137639
• Other study ID #: 143/20-me
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• Platelet-rich fibrin (PRF)
PRF was only applied in the experimental arm to improve wound bed conditions

Locations

Country	Name	City	State
Germany	University Hospital of Würzburg	Würzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coverage rate	The coverage rate was measured 10-14 days after surgery with a photo analysis	10-14 days
Secondary	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