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

University of Florida

Status: Completed

Conditions: Head and Neck Disorder; Free Flap

Treatments: Procedure: Platelet Rich Fibrin (PRF) Application

Study type: Interventional

Funder types: Other

Identifiers

NCT04023474

IRB201901618

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Platelet Rich Fibrin (PRF) Group

Experimental group

Description:

Patients randomized to this group will receive treatment with a PRF graft in clinic at the time any pertinent post-operative complication is identified.

Treatment:

Procedure: Platelet Rich Fibrin (PRF) Application

No Platelet Rich Fibrin Group

No Intervention group

Description:

Participants in the observational control group will be managed at the time of the complication by standard of care methods.