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

N/AEnrolling By InvitationNCT07098715

Mayo Clinic20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fistula-in-ano Draining Wound

Interventions

Kerecis fish skinDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Fistula healing

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.

Time frame: From device implant until 6 months after

Data from ClinicalTrials.gov

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