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Recruiting NCT05804136

Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

No phase Interventional Laparotomy Closure After Abdominal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Duramesh, Polydioxanone suture.
Who it may be relevant to
Registry conditions: Laparotomy Closure After Abdominal Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Device Duramesh
    Laparotomy closure with Duramesh
  • Device Polydioxanone suture
    Laparotomy closure with standard PDS

Primary outcome measures

  • The primary outcome is SSE that occurs within 1 month after surgery. [Time frame: 1 month]
Secondary outcome measures (12)
  • SSE within the first 12 months after repair. [Time frame: 12 months]
  • Clinical hernia occurrence/recurrence within 12 months after repair. [Time frame: 12 months]
  • Return to the operating room (re-interventions) within 12 months for device related issue. [Time frame: 12 months]
  • Surgeon satisfaction at index-procedure using the 5-point smiley face scale. [Time frame: Procedure]
  • Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale. [Time frame: 1 month]
  • Technical success of index-procedure. [Time frame: Procedure]
  • Device performance using the 5-point smiley face scale. [Time frame: Procedure]
  • Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up. [Time frame: 1 month]
  • Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up. [Time frame: 12 months]
  • Palpability/sensation of suture used for the repair at 12-months follow-up. [Time frame: 12 months]
  • Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up. [Time frame: 12 months]
  • Patient satisfaction at 1-month follow-up 5-point smiley face scale. [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • UZ Gent — Ghent

Identifiers

NCT: NCT05804136 · MOMENTUM RCT ONZ-2022-0507

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗