BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

NARecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

February 21, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2026

Conditions
Anal Fistula
Interventions
PROCEDURE

Surgery

Control patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct.

OTHER

Platelet-rich plasma (PRP)

Participants will have 40-50cc of peripheral whole blood drawn into a syringe pre-loaded with acid citrate dextrose (ACD) anticoagulant and concentrated PRP harvested by double centrifugation technique using the manufacturer's kit and benchtop centrifuge. This typically yields 5-8cc of PRP that is 18-times more concentrated than baseline.

DEVICE

Matrix

"Participants will receive 200g of paste matrix and 200g injected at the following sites: the internal opening closure site at level of the sphincter muscle, within the walls of the fistula tract along its length, and within the tissue of an advancement flap particularly at areas of tissue apposition."

Trial Locations (1)

77030

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES

UNKNOWN

lead

The University of Texas Health Science Center, Houston

OTHER

NCT05805449 - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma | Biotech Hunter | Biotech Hunter