Ethibond Suture vs Vessel Loop for Anal Fistulas

Overseen By Sameh H Rizkalla, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Simple anal fistulas, Malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates which material better manages complex anal fistulas—Ethibond suture (a type of braided nylon suture) or vessel loop (a silicone loop). The study focuses on each option's effectiveness in draining infections, their durability, and their impact on patients' quality of life. Individuals with complex anal fistulas due to conditions like inflammatory bowel disease (IBD) might find this trial relevant. Participants will receive one of the two treatments to determine which is more effective and comfortable over time. As an unphased trial, this study allows patients to contribute to valuable research that could enhance treatment options for complex anal fistulas.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these seton materials are safe for managing anal fistulas?

Research has shown that Ethibond sutures are generally safe for people. Studies have found no major problems or side effects when these sutures are used in surgeries, indicating they are well-tolerated.

Regarding vessel loops, studies indicate their frequent use in treating complex anal fistulas. The results have been positive, with long-term outcomes showing a high rate of healing and a low risk of the fistula returning or causing loss of bowel control.

Both treatments are commonly used and have a strong safety record, making them likely safe options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Ethibond Suture and Vessel Loop for treating complex anal fistulas because these methods offer new approaches to managing this challenging condition. Unlike traditional surgical options that might involve more invasive procedures, both Ethibond Suture and Vessel Loop act as drainage setons. This means they are designed to help keep the fistula open and draining properly, potentially leading to better healing and less discomfort for patients. By focusing on drainage rather than more aggressive surgical intervention, these treatments aim to improve patient outcomes with a less invasive approach.

What evidence suggests that this trial's treatments could be effective for anal fistulas?

This trial will compare Ethibond sutures and vessel loops for treating complex anal fistulas. Research has shown that Ethibond stitches are strong and reliable for this purpose. When combined with wire, Ethibond becomes even stronger, enhancing its dependability. Meanwhile, vessel loop setons offer another effective option. Studies have found that using vessel loops for anal fistulas can achieve a healing rate of up to 95%. This trial will compare both materials to evaluate their effectiveness in draining infections and improving the quality of life for individuals with complex anal fistulas. ^{1 2 3 4 6}

Who Is on the Research Team?

Steven D Wexner, M.D.

Principal Investigator

Cleveland Clinic Florida

Are You a Good Fit for This Trial?

This trial is for adults 18 years or older with complex anal fistulas (CAF), including those caused by cryptoglandular infections and inflammatory bowel disease. It's not suitable for individuals who don't meet the specific age and condition requirements.

Inclusion Criteria

I am 18 or older with a type of anal fistula.

Exclusion Criteria

Pregnant women

I have a simple anal fistula.

Patients with pre-existing setons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of Ethibond suture or vessel loop as a drainage seton for complex anal fistulas

12 months

Follow-up

Participants are monitored for changes in quality of life, drainage of perianal sepsis, durability of seton, healing, and continence state

12 months

Regular follow-up visits at 3 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ethibond Suture
• Vessel Loop

Trial Overview The study compares two materials used as drainage setons in managing CAF: Ethibond suture and vessel loop. The goal is to evaluate which material better drains infection, lasts longer without breaking, and improves patients' quality of life.

How Is the Trial Designed?

Group I: Ethibond suture Active Control 1 Intervention

Patients with complex anal fistula will undergo placement of Ethibond™ 1 suture as a drainage seton

Group II: Vessel loop Active Control 1 Intervention

Patients with complex anal fistula will undergo placement of vessel loop as a drainage seton

Ethibond Suture is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Ethibond for:

• General surgical procedures
• Closure of thoracotomy incisions
• Abdominal wall closure
• Anal fistula management

Approved in United States as Ethibond for:

• General surgical procedures
• Closure of thoracotomy incisions
• Abdominal wall closure
• Anal fistula management

Approved in Canada as Ethibond for:

• General surgical procedures
• Closure of thoracotomy incisions
• Abdominal wall closure
• Anal fistula management

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

The electrothermal bipolar vessel sealer (EBVS) demonstrated high safety and efficacy in 98 clinical cases, with only 0.3% requiring alternative ligation techniques due to bleeding, and no postoperative hemorrhagic complications reported.

In an animal model, the EBVS significantly reduced the time for intestinal resections compared to traditional ligatures, completing the procedure in an average of 251.9 seconds versus 702.0 seconds, while also allowing for more applications per minute (7.6 vs. 1.8).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial results with an electrothermal bipolar vessel sealer. Heniford, BT., Matthews, BD., Sing, RF., et al.[2022]

In a study of 68 women undergoing vaginal hysterectomy, electrosurgical bipolar vessel sealing (EBVS) significantly reduced procedure time compared to traditional suturing, with a median duration of 32 minutes versus 40 minutes.

EBVS also resulted in fewer ligatures used (1 vs. 7) and lower postoperative pain scores (median score of 4 vs. 6), indicating it may enhance patient comfort and efficiency during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Cronjé, HS., de Coning, EC.[2016]

The study demonstrated that functional side-to-side small intestinal anastomoses (FSS-SIA) can be effectively created using an electrothermal bipolar vessel sealing (EBVS) device, with histological results showing successful collagenous fusion.

Adding simple interrupted sutures to EBVS anastomoses significantly increased the initial leakage pressure compared to both EBVS alone and stapled anastomoses, suggesting that this technique may enhance the strength of the intestinal connection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ex vivo comparison of leakage pressures and leakage location with a novel technique for creation of functional side-to-side canine small intestinal anastomoses. Chu, KL., Duffy, DJ., Vieson, MD., et al.[2020]

The electrothermal bipolar vessel sealer (EBVS) significantly reduced the mean recipient vessel preparation time to 8.3 minutes compared to 14.5 minutes with conventional silk ligatures, indicating greater efficiency in kidney transplant procedures.

EBVS was found to be a safe and effective method for sealing lymphatic vessels during renal transplantation, potentially reducing the risk of posttransplant lymphatic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective comparison of suture ligation and electrothermal sealing for the control of perivascular lymphatics in kidney transplant recipients. Mehra, K., Kapashi, K., Khemchandani, S., et al.[2023]

Stainless steel wire exhibited the highest load at failure and stiffness compared to Mersilene tape and Ethibond suture, making it the strongest option for rigid fixation applications.

Multiple loops of Ethibond suture can effectively substitute for stainless steel wire in compliant repairs, such as patellar tendon support, but may not be suitable for applications requiring rigid fixation, like tension band fixation of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the mechanical properties of different tension band materials and suture techniques. Harrell, RM., Tong, J., Weinhold, PS., et al.[2022]

In a study involving 82 patients undergoing aortic or mitral valve replacement, both Trubond® and Ethibond® braided polyester sutures showed no incidence of paravalvular leak (PVL) or other postoperative complications within 26 weeks, indicating their safety and efficacy.

Trubond® braided polyester suture was found to be clinically equivalent to Ethibond® in terms of suture handling, operative time, and postoperative recovery, making it a viable option for valve fixation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Equivalence of Trubond® and Ethibond® Braided Polyester Sutures for Valvular Prosthesis Fixation During Aortic or Mitral Valve Replacement: A Single-Blind Randomized Controlled Trial. Desai, NB., Bhat, PSS., M, CS., et al.[2023]

In a study involving 52 patients, four different suture materials (Ethibond Excel, Monocryl, silk, and Vicryl) were compared in terms of their handling, resistance, and tissue response during oral surgery, with evaluations made at both 3 weeks and 90 days post-surgery.

While the clinical healing outcomes at 90 days were similar across all suture types, differences were noted in the early postoperative period, indicating that the choice of suture material may impact short-term recovery and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suture in oral surgery. A comparative study. Arcuri, C., Cecchetti, F., Dri, M., et al.[2022]

A new suture material called Ethibond is created by applying a polybutylate coating to braided polyester fiber, enhancing its handling properties.

Ethibond demonstrates reduced tissue drag and minimal tissue reactivity, making it potentially safer and more effective for surgical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethibond--a new polybutylate coated polyester suture. Capperauld, I.[2019]

The FiberLoop suture demonstrated significantly greater strength compared to Ethibond in tendon repairs, indicating its potential for more effective surgical outcomes.

Both FiberLoop and FiberWire sutures were found to be equally strong, suggesting that the double-armed design of FiberLoop could allow for faster tendon repairs without compromising strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of FiberLoop sutures in locking and nonlocking tendon repair. Cash, MP., Sherrill, JM., Waitayawinyu, T., et al.[2019]

Reusable loop stitches, specifically the free-loop and loose-loop suture techniques, effectively secure stents in skin grafts, allowing for easy access to the graft site.

These suture methods enable repeated rethreading without the need for additional anesthesia, making them a practical choice for ongoing patient care and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reusable loop stitches for inspection of grafts. Snow, SN., Larson, PO., Olansky, D.[2019]

In a study involving 45 bovine knees, the new suture material FiberWire demonstrated biomechanical properties comparable to the standard Ethibond suture when used for tendon repair and augmentation, indicating its potential as a reliable alternative.

The combination of Ethibond with FiberWire was found to be significantly weaker than both the FiberWire-only and Ethibond/wire repairs, suggesting that using FiberWire alone or with itself may provide better strength in surgical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biomechanical comparison of patellar tendon repair materials in a bovine model. Flanigan, DC., Bloomfield, M., Koh, J.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7260917/

The effect of suture selection in complex anal fistulas on ... The aim of our study was to compare the success rates of suture selection, recovery times and pain associated with local wound infection and seton placement ...

2. withpower.com withpower.com/trial/phase-rectal-fistula-6-2023-863de

Ethibond Suture vs Vessel Loop for Anal Fistulas The research indicates that Ethibond sutures are strong and reliable, as shown in a study where Ethibond combined with wire was significantly stronger than ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772632022000150

Advancing standard techniques for treatment of perianal ... The rectal advancement flap (RAF) is a sphincter-preserving technique with a 66–87% healing rate. It has been suggested that it could be an optimal technique ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05933343/ethibond-suture-vs-vessel-loop-as-draining-seton-for-complex-anal-fistulas?state=FL&city=Weston

Ethibond Suture vs Vessel Loop as Draining Seton ... 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6400914/

Suture choice to reduce occurrence of surgical site infection ... Furthermore, nylon sutures proved more effective than polyglycolic acid, polyglyconate and Ethibond sutures at preventing hernia formation postoperatively.

6. journals.lww.com journals.lww.com/wjcs/fulltext/2020/09040/nigam_s_modified_roeder_s_knot_in_cutting_seton_in.2.aspx

s Modified Roeder′s Knot in Cutting Seton in High... : ... Use of a cutting seton is an accepted mode of treatment for high fistula-in-ano cases. Nigam's modified Roeder's knot (NMRK) makes the cutting seton adjustable.