Recruiting

Acellular Matrix & PRP

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05805449

Conditions

Anal Fistula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgery

Platelet-rich plasma (PRP)

Matrix

Study Details

Brief summary:

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

Conditions

Anal Fistula

Study ID

NCT05805449

Start date

Feb 21, 2023

Status verified date

Apr, 2023

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Surgery

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

experimental: Surgery plus platelet-rich plasma (PRP)

experimental: Surgery plus matrix

experimental: Surgery plus PRP plus matrix material

Interventions

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.

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.

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.

Primary outcome measure

  • Number of participants with fistula recurrence [ Time Frame: upto 6 months after surgery ]
  • Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire [ Time Frame: Baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery. ]

Central Contacts and Locations

Central contacts

Jeffrey L Van Eps, MD

713-486-4600Jeffrey.L.VanEps@uth.tmc.edu

Angielyn Rivera

713-416-1350Angielyn.R.Rivera@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jeffrey L Van Eps, MD

713-486-4600Jeffrey.L.VanEps@uth.tmc.edu

Angielyn Rivera

713-416-1350Angielyn.R.Rivera@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 10, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2023-04-10.