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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2027-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Fistula-in-ano Draining Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intact 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.

Group Type EXPERIMENTAL

Kerecis fish skin

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No