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Enrolling by invitation NCT07098715

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

No phase Interventional Fistula-in-ano Draining Wound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kerecis fish skin.
Who it may be relevant to
Registry conditions: Fistula-in-ano, Draining Wound. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Fistula healing [Time frame: From device implant until 6 months after]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07098715 · 24-007753

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗