Back to resultsFree Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Platelet-rich fibrin (PRF)
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
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
Sites / Locations
- University Hospital of Würzburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PRF group
non-PRF group
Arm Description
Participants received platelet-rich fibrin (PRF) prior to free skin grafting
Standard surgical procedure (free skin grafting to reconstruct donor sites without PRF).
Outcomes
Primary Outcome Measures
Coverage rate
The coverage rate was measured 10-14 days after surgery with a photo analysis
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05137639
First Posted
November 12, 2021
Last Updated
November 26, 2021
Sponsor
Wuerzburg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05137639
Brief Title
Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting
Official Title
Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting: A Prospective Study With Platelet-rich Fibrin (PRF)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRF group
Arm Type
Experimental
Arm Description
Participants received platelet-rich fibrin (PRF) prior to free skin grafting
Arm Title
non-PRF group
Arm Type
No Intervention
Arm Description
Standard surgical procedure (free skin grafting to reconstruct donor sites without PRF).
Intervention Type
Procedure
Intervention Name(s)
Platelet-rich fibrin (PRF)
Intervention Description
PRF was only applied in the experimental arm to improve wound bed conditions
Primary Outcome Measure Information:
Title
Coverage rate
Description
The coverage rate was measured 10-14 days after surgery with a photo analysis
Time Frame
10-14 days
Secondary Outcome Measure Information:
Title
Evaluation Score (ES)
Description
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.
Time Frame
10-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Straub, MD
Organizational Affiliation
Dep. of Oral and Maxillofacial Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Würzburg
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97070
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting
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