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

Not Applicable

Not yet recruiting

• Conditions: Fistula-in-ano; Draining Wound

• Registration Number: NCT07098715
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Study Start: 2025-09-01
• Primary Completion: 2026-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States