Platelet-Rich Fibrin in the Healing of Regional and Free Flaps

Free Flap Clinical Trial

Official title:

Role of Platelet-Rich Fibrin in the Healing of Regional and Free Flap Donor Sites for Head and Neck Surgery Patients: A Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023474
• Other study ID #: IRB201901618
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods improves the post-operative management of healing complications from flap donor sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who had surgery involving a microvascular free flap or a myocutaneous regional flap for head and neck reconstruction who develop one of the following donor site complications: wound dehiscence, wound margin breakdown or contraction resulting in healing by secondary intention, myocutaneous fistula formation, or incomplete coverage of the donor site by a skin graft placed in the operating room.

Exclusion Criteria:

• Patients under 18 years of age

• Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.

Related Conditions & MeSH terms

• Free Flap
• Head and Neck Disorder

Intervention

Procedure:
• Platelet Rich Fibrin (PRF) Application
Platelet Rich Fibrin application to flap defect.

Locations

Country	Name	City	State
United States	UF Health Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in healing time at 3 months post-operative	Improved healing of PRF patients compared to control group.	Up to 3 months