NCT05137639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

November 12, 2021

Last Update Submit

December 6, 2023

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Coverage rate

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

    10-14 days

Secondary Outcomes (1)

  • Evaluation Score (ES)

    10-14 days

Study Arms (2)

PRF group

EXPERIMENTAL

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

Procedure: Platelet-rich fibrin (PRF)

non-PRF group

NO INTERVENTION

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

Interventions

Platelet-rich fibrin (PRF)PROCEDURE

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

PRF group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Würzburg

Würzburg, Bavaria, 97070, Germany

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Anton Straub, MD

    Dep. of Oral and Maxillofacial Plastic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 30, 2021

Study Start

October 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

December 7, 2023

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)