Anal FistulaBIO RAMPNCT05805449
BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
A study testing Surgery, Platelet-rich plasma (PRP) and Matrix in people with Anal Fistula, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Surgery, Platelet-rich plasma (PRP) and Matrix
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jeffrey L Van Eps, MD, 713-486-4600, Jeffrey.L.VanEps@uth.tmc.edu
Angielyn Rivera, 713-416-1350, Angielyn.R.Rivera@uth.tmc.edu
About this study
Official title: The BIO RAMP Trial - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
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
- Being tested
- Surgery, Platelet-rich plasma (PRP), Matrix
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or 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)Other
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.
MatrixDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Sham comparator | 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. Receives: Procedure: Surgery |
| Surgery plus platelet-rich plasma (PRP) | Experimental | Not described Receives: Procedure: Surgery; Other: Platelet-rich plasma (PRP) |
| Surgery plus matrix | Experimental | Not described Receives: Procedure: Surgery; Device: Matrix |
| Surgery plus PRP plus matrix material | Experimental | Not described Receives: Procedure: Surgery; Other: Platelet-rich plasma (PRP); Device: Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with fistula recurrence
A fistula recurrence is defined as one or more of the following clinical signs or symptoms after repair: recurrent abscess at the site of repair, chronic drainage or passage of flatus from an external opening of the perineum away from the anal verge, a non-healing external opening that tracks toward anus by probing with fistula probe.
Measured: upto 6 months after surgery
Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire
This instrument queries subjects on health status related to mobility, self-care, 'usual' activities, pain/discomfort, and anxiety/depression with 5 potential responses ranging from "no problems" to inability to complete the task or extreme levels of pain/depression, correlating to a discrete index score from 1-5, a higher number indicating a worse outcome.The instrument also includes an overall VAS self-rating of health ranging from 0-100, higher number indicating better health.
Measured: 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.
Secondary outcomes (3)
Number of participants who have post operative pain as assessed by the visual analog scale (VAS)
This is scored from 0-100, higher number indicating better health
Measured: 14 days after surgery
Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool
This is a 5 item questionnaire that assesses type of incontinence (solid, liquid, gas, wears pad, lifestyle alteration).
The frequency with which each type of incontinence occurs is rated on a scale from 0 (never) to 4 (always or to 1/day). The sum of the frequencies is added to yield a total score that can range from 0 to 20, with higher scores indicating higher levels of incontinence.
Measured: Baseline, 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery and 12 months after surgery
The relative cost utility of the different treatment strategies as assessed by a questionnaire
A cost effectiveness analysis (CEA) will be done from the healthcare system perspective assessed as the incremental health system costs (or savings) per fistula recurrence prevented
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start21 Feb 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
- Responsible party
- Principal investigator, Jeff Van Eps, MD, The University of Texas Health Science Center, Houston
- Investigators
- Jeffrey L Van Eps, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805449
- Sponsor's protocol ID
- HSC-MS-22-0759
- Acronym
- BIO RAMP
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BIO RAMP Trial - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
- ClinicalTrials.gov ID
- NCT05805449
- Acronym / sponsor ID
- BIO RAMP / HSC-MS-22-0759
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgery | Sham comparator | Procedure: SurgeryControl 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. |
| Surgery plus platelet-rich plasma (PRP) | Experimental | Procedure: Surgery, Other: Platelet-rich plasma (PRP) |
| Surgery plus matrix | Experimental | Procedure: Surgery, Device: Matrix |
| Surgery plus PRP plus matrix material | Experimental | Procedure: Surgery, Other: Platelet-rich plasma (PRP), Device: Matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryControl patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct. | Procedure or surgery | Surgery, Surgery plus PRP plus matrix material, Surgery plus matrix, Surgery plus platelet-rich plasma (PRP) |
| 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. | Other | Surgery plus PRP plus matrix material, Surgery plus platelet-rich plasma (PRP) |
| MatrixParticipants 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. | Device | Surgery plus PRP plus matrix material, Surgery plus matrix |
Primary outcome
Number of participants with fistula recurrence
Time frame: upto 6 months after surgery
A fistula recurrence is defined as one or more of the following clinical signs or symptoms after repair: recurrent abscess at the site of repair, chronic drainage or passage of flatus from an external opening of the perineum away from the anal verge, a non-healing external opening that tracks toward anus by probing with fistula probe.
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.
This instrument queries subjects on health status related to mobility, self-care, 'usual' activities, pain/discomfort, and anxiety/depression with 5 potential responses ranging from "no problems" to inability to complete the task or extreme levels of pain/depression, correlating to a discrete index score from 1-5, a higher number indicating a worse outcome.The instrument also includes an overall VAS self-rating of health ranging from 0-100, higher number indicating better health.
3 secondary outcomes
Number of participants who have post operative pain as assessed by the visual analog scale (VAS)
Time frame: 14 days after surgery
Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool
Time frame: Baseline, 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery and 12 months after surgery
The relative cost utility of the different treatment strategies as assessed by a questionnaire
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Anal Fistula
Active, not recruitingPhase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Anal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Active, not recruiting
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Fistula-in-ano, Draining Wound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Van Eps, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery, Platelet-rich plasma (PRP) and Matrix in people with Anal Fistula, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey L Van Eps, MD (713-486-4600, Jeffrey.L.VanEps@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with fistula recurrence (time frame: upto 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.