Ethibond Suture vs Vessel Loop as Draining Seton for Comp... | NCT05933343

Studies
Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas

NCT05933343

Sponsor

The Cleveland Clinic

Status

Terminated

Last Update Posted

Oct 20, 2025Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Anal Fistula

Interventions

Ethibond suture
Vessel loop

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit the required number of patients as per the sample size calculated

Expanded Access Info

Start Date

Dec 10, 2023Actual

Primary Completion Date

Oct 16, 2025Actual

Completion Date

Oct 16, 2025Actual

First Submitted Date

Jun 28, 2023

First Submission Date that Met QC Criteria

Jun 28, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2025

Last Update Posted Date

Oct 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rizkalla, Sameh M.D., Project Scientist, The Cleveland ClinicPrincipal Investigator

Lead Sponsor

The Cleveland ClinicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.

Detailed Description

The use of seton as a surgical therapy for fistulous disease has been first described by Hippocrates in 430 BCE. Since then several authors have used either cutting or drainage seton to treat CAF. Different materials have been used as seton, including sutures, stainless steel wires, catheters, cables, silicone, and rubber bands. While the main aim of a drainage seton is to simply drain sepsis and control symptoms in the long term, cutting setons are mainly used for eradiation of the fistula pathology by cutting through the fistula tract and anal sphincter muscles, yet at the cost of an increased risk of fecal incontinence (FI).

As the purpose of a drainage seton is to provide long-term, durable drainage of perineal sepsis and control of symptoms, namely discharge, the seton material can have an impact on its function and durability. A review of the variations in seton types and materials showed that the success rates of suture seton (silk, prolene or nylon suture) are higher than those of Penrose drains and catheters. However, there is a paucity of data on the impact of the seton material on the durability of seton and quality of life (QoL)

Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability, and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ethibond suture	Active Comparator	Patients with complex anal fistula will undergo placement of Ethibond™ 1 suture as a drainage seton	Procedure: Ethibond suture
Vessel loop	Active Comparator	Patients with complex anal fistula will undergo placement of vessel loop as a drainage seton	Procedure: Vessel loop

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethibond suture	Procedure	An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula	Ethibond suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Drainage of perianal sepsis	Change in the perianal disease activity index	3 and 12 months
Durability	Incidence and timing of seton break/fall	within 12 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life score	Change in the anal fistula quality of life score which ranges from 14 to 70 and higher values imply greater impact on quality of life	3 and 12 months
Healing	Complete healing of the anal fistula evidenced by absence of external opening and discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients aged 18 years or older of either sex who present with CAF will be included. Both cryptoglandular fistulas and fistulas secondary to inflammatory bowel disease (IBD)

Exclusion Criteria:

Simple anal fistulas
Fistulas secondary to malignancy or irradiation therapy
Pregnant women
Patients with pre-existing setons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven D Wexner, M.D.	Cleveland Clinic Florida	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Florida		Weston	Florida	33331	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012003	Rectal Fistula

Ancestor Terms

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided