Draining Wound, Fistula-in-ano
Conditions
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.
Interventions
DEVICEKerecis 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed