A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose

NCT07098715 — Not applicable, Active not recruiting, 20 participants, Mayo Clinic

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Closure Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose

Registry	NCT07098715
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Fistula-in-ano, Draining Wound
Interventions	Kerecis fish skin (Device)
Dates	start 2025-09-11, primary completion 2026-10-28 (estimated), completion 2027-09-01 (estimated), first posted 2025-08-01, last updated 2026-10-08
Locations	1 site in United States

-Summary

The purpose of this study is to determine feasibility of Kerecis intact fish skin for healing of fistula-in-ano and associated non-healing draining wounds.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Intact Kerecis Fish Skin	Experimental	Device: Kerecis fish skin	To assess shot-term outcomes (rates of healing) using Kerecis intact fish skin to heal cryptoglandular fistula-in-ano and associated chronic non-healing draining wounds.

Kerecis fish skin (Device): To assess shot-term outcomes (rates of healing) using Kerecis intact fish skin to heal cryptoglandular fistula-in-ano and associated chronic non-healing draining wounds.

+Outcome measures

Primary outcomes

Fistula healing [From 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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adults age ≥18 years old
* Cryptoglandular fistula-in-ano (primary or recurrent)
* The ability to give appropriate consent

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States

+Investigators

Nicholas P. McKenna, MD, Principal investigator, Mayo Clinic