This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High Perianal Fistula Treatment. The Study Aims to Determine Whether the GLUBRAN®-Coated Seton Improves Healing, Reduces Postoperative Pain and Recurrence, and Better Preserves Anal Continence.

June 27, 2026 updated by: Ahmed Monged Ibrahim Yousef Swedan, Kasr El Aini Hospital

Comparative Study Between Regular Seton and GLUBRAN® Coated Seton in the Management of High Anal Fistula (Novel Technique)

High anal fistula is a complex anorectal condition that can cause persistent pain, purulent discharge, recurrent infection, and a significant reduction in quality of life. The conventional cutting seton technique is an established treatment modality; however, it may be associated with postoperative pain, delayed healing, recurrence, and impairment of anal continence. GLUBRAN® is a synthetic surgical adhesive with antimicrobial and tissue-healing properties that may enhance the performance of the cutting seton and improve clinical outcomes.

This randomized controlled clinical trial aims to compare the efficacy and safety of a conventional cutting seton with a GLUBRAN®-coated cutting seton in adult patients with high anal fistulas. Eligible participants will be randomly allocated to one of the two treatment groups and followed for six months after surgery. The primary and secondary outcome measures will include fistula healing rate, time to complete healing, postoperative pain, anal continence, recurrence, postoperative complications, and length of hospital stay.

The findings of this study may provide evidence regarding whether coating a cutting seton with GLUBRAN® offers clinical advantages over the conventional technique, potentially leading to improved healing, reduced postoperative morbidity, and better preservation of anal continence in the management of high anal fistulas.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

High anal fistula is a challenging anorectal disorder characterized by an abnormal communication between the anal canal and the perianal skin that involves a significant portion of the anal sphincter complex. Patients with high anal fistulas commonly present with persistent perianal pain, recurrent abscess formation, purulent discharge, local irritation, and a substantial reduction in quality of life. These fistulas are considered complex because of their anatomical relationship with the anal sphincter muscles and the increased risk of postoperative continence impairment following surgical treatment. Consequently, the ideal management strategy should achieve complete eradication of the fistula tract while preserving sphincter function and minimizing the risk of recurrence.

The cutting seton technique has long been used as a sphincter-preserving surgical approach for the management of high anal fistulas. The procedure involves placement of a seton through the fistula tract, allowing gradual division of the sphincter muscle while promoting fibrosis and controlled healing. Although this technique has demonstrated satisfactory healing rates in numerous studies, concerns remain regarding postoperative pain, prolonged healing time, recurrence, local infection, and varying degrees of fecal incontinence. Therefore, ongoing efforts have focused on identifying modifications that may improve clinical outcomes while maintaining the effectiveness of the procedure.

GLUBRAN® is a synthetic cyanoacrylate-based surgical adhesive that has been used in multiple surgical specialties because of its adhesive, hemostatic, sealing, and bacteriostatic properties. Experimental and clinical evidence suggests that cyanoacrylate-based materials may reduce bacterial colonization, attenuate local inflammatory responses, provide mechanical support to healing tissues, and promote tissue repair. Coating a cutting seton with GLUBRAN® may therefore enhance the therapeutic effect of the procedure by reducing local infection, minimizing tissue irritation, facilitating wound healing, and potentially decreasing postoperative complications. Despite these theoretical advantages, there is currently limited clinical evidence directly comparing GLUBRAN®-coated cutting setons with conventional cutting setons in the management of high anal fistulas.

This study is designed as a prospective, randomized controlled clinical trial conducted at Cairo University Hospitals to evaluate the efficacy and safety of GLUBRAN®-coated cutting setons compared with conventional cutting setons in adult patients with high anal fistulas. Eligible participants will include patients aged 18 years or older with high trans-sphincteric, suprasphincteric, extrasphincteric, or otherwise complex anal fistulas confirmed by clinical examination and magnetic resonance imaging (MRI) fistulography. Patients with Crohn's disease, tuberculosis, malignancy-associated fistulas, radiation-induced fistulas, active perianal abscesses, or significant uncontrolled medical conditions that may interfere with wound healing will be excluded.

Following enrollment, participants will be randomly allocated in a 1:1 ratio to one of two treatment groups. Patients assigned to the control group will undergo conventional cutting seton placement using silk suture material. Patients assigned to the intervention group will undergo placement of a silk cutting seton coated with GLUBRAN® surgical adhesive before insertion through the fistula tract. All procedures will be performed according to standardized operative techniques, and all participants will receive standardized postoperative care, including analgesia, antibiotic therapy when indicated, and scheduled outpatient follow-up.

Participants will be monitored throughout the postoperative period and during a six-month follow-up. Clinical assessments will evaluate wound healing, symptom resolution, postoperative pain, continence status, recurrence, and treatment-related complications. Pain severity will be assessed using the Numerical Rating Scale (NRS), while continence will be evaluated using the validated Wexner Continence Score. Additional outcome measures will include postoperative infection, abscess formation, bleeding, length of hospital stay, need for reintervention, and overall postoperative recovery.

The primary objectives of this study are to compare complete healing rates, time to complete healing, and preservation of anal continence between the two treatment groups. Secondary objectives include comparing postoperative pain, complication rates, recurrence rates, and length of hospital stay. By systematically evaluating these outcomes, this study seeks to determine whether coating a cutting seton with GLUBRAN® provides clinically meaningful benefits over the conventional technique.

The results of this trial are expected to provide valuable evidence regarding the role of GLUBRAN® in the management of high anal fistulas. If shown to improve healing while reducing postoperative complications and preserving anal continence, GLUBRAN®-coated cutting setons may represent a safe and effective modification of the conventional cutting seton technique. The findings may help guide future surgical practice, optimize patient outcomes, and improve the quality of care provided to patients with this challenging condition.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza Governorate
      • Giza, Giza Governorate, Egypt, 11562
        • Kasr Al Ainy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: - Patients diagnosed with high trans-sphincteric/Extrasphinteric/supra-sphincteric/complex Fistula confirmed clinically and MRI Fistulogram

  • Age ≥ 18 years
  • Patients fit for surgery.

Exclusion Criteria:

  • Patients with Crohn's disease, tuberculosis, malignancy, or radiation-associated fistulas (due to different healing patterns and management protocols).
  • Presence of acute perianal abscess at the time of surgery
  • Patients with uncontrolled comorbidities (e.g., diabetes mellitus, bleeding disorders, immunosuppression) that could affect healing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glubran-coated Seton
Using Glubran combined with Seton in the managment of high/complex perianal fistula
Procedure: Glubran-coated Seton
Using 2 ampules of no. 1 Vicryl suture as a Seton combined with Glubran 2 in the management of high/complex perianal fistula
Active Comparator: Seton
Using regular Seton that is already established in the management of high/complex perianal fistula
Procedure: Seton
Using 2 ampules of no. 1 Vicryl as a regular Seton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continence
Time Frame: 6 months
Assessment of continence status using a validated scoring system (e.g., Wexner Incontinence Score) to compare the impact of both techniques on sphincter function. (0 - 20) 0 being no incontinence, and 20 being no continence.
6 months
Healing Rate
Time Frame: 6 months
To compare the complete healing rate and time of complete healing after treatment using either Seton placement or GLUBRAN®-coated Seton over a standardized follow-up period of 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Stay Duration
Time Frame: 2 days
Hospital Stay Duration
2 days
Incidence of complications such as infection, abscess formation, bleeding.
Time Frame: 6 months
Incidence of complications such as infection, abscess formation, bleeding.
6 months
Recurrence
Time Frame: 6 months
Short-term Recurrence Rate
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Study Chair: Ismail A Shafik, M.D., Kasr El Aini Hospital
  • Study Director: Abdelrahman M. Ibrahim, M.D., Kasr El Aini Hospital
  • Principal Investigator: Ahmed Y. Ahmed, M.D., Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2026

Primary Completion (Estimated)

July 11, 2026

Study Completion (Estimated)

July 11, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 27, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-682-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly due to patient confidentiality considerations, the sensitive nature of clinical surgical data, and institutional data protection policies. Only aggregated results will be reported.

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: https://docs.google.com/spreadsheets/d/1eZjb7Xju7cntbPTareModXlZGJnS0d2k/edit?usp=drive_link&ouid=114042876965075600816&rtpof=true&sd=true
  2. Study Protocol
    Information comments: https://docs.google.com/document/d/195jb55EeL0QlIpf659zT3y2dg3x_eRGt/edit?usp=drive_link&ouid=114042876965075600816&rtpof=true&sd=true

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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