Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly

Study Overview
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Brief Summary
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The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.

Official Title
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Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly

Conditions
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Anal Fistula

Intervention / Treatment
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* Biological: SygeLIX-F + SygeLIX-G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 to 65 years. Patient with a single anal fistula resistant after at least one surgical treatment. Fistula may be related to Crohn's disease. Patient with an upper transsphincteric or lower transsphincteric fistula. Patient presenting fistula with or without intersphincteric diverticula. Fistula effectively drained with a seton. Informed and consenting patient. Patient who is a member or a beneficiary of a national health insurance plan. Exclusion Criteria: Pregnant or breastfeeding woman or woman of childbearing age without effective contraception. Patients who have had more than one failed obstruction technique. Patient with more than one internal orifice. Patient with an MRI proven abscess. Patient with an uncontrolled infection. Patient with a contraindication to anesthesia. Person deprived of liberty by a judicial or administrative decision. Adult subjected to a legal protection measure or unable to express his / her consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SygeLIX-F + SygeLIX-G<br>Combination of SygeLIX-F, a plug made of an assembly of umbilical cord lining and Wharton's jelly in the form of a cylinder of porous structure, and SygeLIX-G, a Wharton's jelly gel reconstituted in a syringe. | Biological: SygeLIX-F + SygeLIX-G<br>* SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of intensity of perineal inflammation following treatment | Scoring of pain (0 = no pain, 10 = worst pain possible), redness (0 = no redness, 4 = redness covering an area > 5 cm), edema (0 = no edema, 4 = area completely swollen), ulceration (0 = no ulceration, 4 = ulcer larger than 1 cm). | Through study completion (45 days) | 
| Rate of plug expulsion and surgical revision due to complications |  | Through study completion (45 days) | 
| Type and incidence of adverse events (AE) and serious adverse events (SAE) |  | Through study completion (45 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of surgical technique | Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use. | Time of investigational products surgical implantation (Day 0) | 
| Plug integration | Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent). | 30 days, 45 days | 
| Cessation of fistula flow | Healing of the fistula orifices assessed by palpation and pinching. | 45 days |