BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Apr 5, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at new ways to improve the surgical repair of complex anal fistulas, which are abnormal connections between the anal canal and the skin. Researchers want to see if adding treatments such as autologous platelet-rich plasma (PRP) or a special type of tissue called acellular matrix can help reduce the chances of the fistula coming back after surgery. They will also evaluate if these treatments can make recovery easier by reducing pain and improving bowel control, as well as determine if they are cost-effective compared to standard surgical care.
To participate in this study, individuals must be aged between 65 and 74 and have a specific type of anal fistula that requires surgery. They should be able to speak English or Spanish and agree to a temporary drainage procedure before the repair. Participants will be monitored for up to 12 months after their surgery to see how well the treatments work. It’s important for potential participants to be aware that they cannot have certain medical conditions or be on specific medications that could affect their participation.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • complex cryptoglandular transsphincteric anal fistula undergoing surgical repair by LIFT or advancement flap procedure
- • English or Spanish speaking and capable of providing informed consent
- • Willing to undergo temporary anal seton drainage for requisite time prior to repair
- • Participating surgeons will only be eligible if they perform at least 3 repair procedures/year
- Exclusion Criteria:
- • Unable to reliably complete follow up for 12 months postoperatively
- • Primary platelet disorders
- • Thrombocytopenia \< 150 plt/microliter
- • Inability to stop anti-platelet agent \> 5 days preoperatively
- • Fistula associated with inflammatory bowel disease (IBD), malignancy or pelvic/perineal radiation
About The University Of Texas Health Science Center, Houston
The University of Texas Health Science Center at Houston (UTHealth) is a leading academic institution dedicated to advancing health through education, research, and clinical practice. As a prominent sponsor of clinical trials, UTHealth leverages its extensive resources and expertise in biomedical research to facilitate innovative studies aimed at improving patient outcomes. The institution is committed to fostering a collaborative environment that promotes scientific discovery and the translation of research findings into effective healthcare solutions, all while adhering to the highest ethical standards and regulatory guidelines. With a multidisciplinary approach, UTHealth plays a critical role in addressing complex health challenges and enhancing the quality of life in diverse communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Patients applied
Trial Officials
Jeffrey L Van Eps, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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