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

NCT ID: NCT05137639

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PRF group

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

Group Type EXPERIMENTAL

Platelet-rich fibrin (PRF)

Intervention Type PROCEDURE

PRF was only applied in the experimental arm to improve wound bed conditions

non-PRF group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet-rich fibrin (PRF)

PRF was only applied in the experimental arm to improve wound bed conditions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \>18 years, donor site on the forearm after radial forearm flap surgery, free skin graft reconstruction of this skin defect, informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anton Straub, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Oral and Maxillofacial Plastic Surgery

Locations

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University Hospital of Würzburg

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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143/20-me

Identifier Type: -

Identifier Source: org_study_id