Duramesh™ vs Polydioxanone Suture for Laparotomy Closure (MOMENTUM RCT)

A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure

This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.

Study Overview

• Status: Recruiting
• Conditions: Laparotomy Closure After Abdominal Surgery
• Intervention / Treatment: Device: Duramesh; Device: Polydioxanone suture

Detailed Description

This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorien Haesen, PhD; Phone Number: +32 11 28 69 48; Email: dorien.haesen@archerresearch.eu

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Gent
      • Contact: Frederik Berrevoet, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or greater
• Abdominal laparotomy 5 cm in length or greater, either midline or non-midline
• Isolated ostomy site takedown with or without parastomal hernia
• Patient accepts participation and gives informed consent
• Patient and investigator signed and dated the informed consent form prior to the index-procedure

Exclusion Criteria:

• Pregnancy
• Presence of clinically recognized hernia at laparotomy site (parastomal hernia noted at time of ostomy site takedown is not an exclusion criterion. Subclinical incidental small hernia < 1 cm in greatest dimension found at the time of a laparotomy is not an automatic exclusion criterion)
• Prior hernia repair at laparotomy site
• Use of planar mesh in addition to sutures for closure
• CDC IV dirty or infected wound that causes the surgeon to leave the abdominal wall or skin incision open
• Life expectancy less than 1 year
• Patient is unable / unwilling to provide informed consent
• Patient is unable to comply with the protocol or proposed follow-up visits
• Patient is enrolled in another abdominal wall study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Duramesh; Laparotomy closure is associated with the occurrence of Surgical Site Events (SSEs) such as wound dehiscence and incisional hernias. Abdominal wall closure can also cause pain and discomfort, or can lead to intestinal obstruction. Standard sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge leading to repair failure. Meshes distribute forces and allow for tissue ingrowth. Duramesh combines the desirable principles of a mesh repair with the placement precision of a suture. It is the world's first device that both approximates tissue and allows ingrowth for a strong early repair. Consequently, the expected clinical benefit is the reduced occurrence of Surgical Site Events such as incisional hernias. Additional benefits may include reduced pain and improved quality of life due to durable closure of the abdominal wall with Duramesh. This will be evaluated in this randomized study. Size 1 Duramesh is used in this RCT. Duramesh is CE-marked.	Device: Duramesh; Laparotomy closure with Duramesh
Other: Standard suture; 2-0, 0, or Number 1 polydioxanone suture (PDS) is used as comparator.	Device: Polydioxanone suture; Laparotomy closure with standard PDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is SSE that occurs within 1 month after surgery.	This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month). SSE include: Seroma, Hematoma, Soft tissue breakdown, Fascial dehiscence, Cellulitis, Suture granuloma, Chronic draining sinus, Enterocutaneous fistula, Superficial, deep and organ/space infections, Other	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSE within the first 12 months after repair.	SSE include: Surgical incision wound (this does NOT include a less than 5 mm scar-related superficial wound due to scar instability), Chronic draining sinus, Enterocutaneous fistula, Persistent seroma or fluid collection between the abdominal wall incision and the skin but not draining, Other	12 months
Clinical hernia occurrence/recurrence within 12 months after repair.	This study is intended to demonstrate Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.	12 months
Return to the operating room (re-interventions) within 12 months for device related issue.	Re-interventions are defined as: All re-interventions relating to abdominal wall closure complications or abdominal re-exploration.	12 months
Surgeon satisfaction at index-procedure using the 5-point smiley face scale.		Procedure
Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.		1 month
Technical success of index-procedure.	Technical success is defined as successful abdominal wall closure without unexpected difficulties.	Procedure
Device performance using the 5-point smiley face scale.		Procedure
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.	The pain NRS is a single 11-point numeric scale with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondents selects a whole number (0 to 10 integers) that best reflects the intensity of their pain. Pain will be scored in rest and with activity. Activity is defined as activity of daily living, e.g. walking, driving, getting into a car, setting the dinner table, doing the laundry, etc.	1 month
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.	The pain NRS is a single 11-point numeric scale with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondents selects a whole number (0 to 10 integers) that best reflects the intensity of their pain. Pain will be scored in rest and with activity. Activity is defined as activity of daily living, e.g. walking, driving, getting into a car, setting the dinner table, doing the laundry, etc.	12 months
Palpability/sensation of suture used for the repair at 12-months follow-up.	Assessment whether the patient can feel the suture.	12 months
Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.	The SF-12 Health Survey is a 12-item, patient-reported survey of patient health.	12 months
Patient satisfaction at 1-month follow-up 5-point smiley face scale.		1 month
Patient satisfaction at 12-months follow-up 5-point smiley face scale.		12 months

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Anticipated): February 28, 2025
• Study Completion (Anticipated): September 30, 2026

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MOMENTUM RCT ONZ-2022-0507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No