NCT07098715
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Enrolling by Invitation
NAAges 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~20 participants
Updated 2025-09-19 on ClinicalTrials.gov
What's tested:Kerecis fish skin
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fistula healing
Measured over From device implant until 6 months after
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Nicholas P. McKenna, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adults age ≥18 years old
Cryptoglandular fistula-in-ano (primary or recurrent)
The ability to give appropriate consent
Exclusion
Age \<18 years old
Pregnant (as determined by urine test)
Any known allergies or sensitivities to fish material
Prisoners
Inflammatory bowel disease
Fistula-in-ano associated with:
Anal cancer
Rectal cancer
Extramammary Paget's disease
Hidradenitis suppurativa
Anal condyloma
Active infection / abscess
What this trial measures
- Fistula healingFrom device implant until 6 months after
Assess healing of the fistula. This will be determined based on physical examination. A healed fistula will be a patient who 6 months after surgery no longer has drainage or evidence of infection. The internal opening should be closed on physical exam. The internal opening should feel closed on digital rectal exam. This will be assessed in each patient to determine the overall rate of healing.