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

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.

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Key information

Conditions

Fistula-in-ano Digestive System Diseases Digestive System Fistula Draining Wound Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Fistula healing

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Aug 1, 2025
Registry last updated: Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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