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NCT Number: NCT05804136

Duramesh™ vs 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.

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Key information

Conditions

Laparotomy Closure After Abdominal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location status: Recruiting

Location contact

Frederik Berrevoet, Prof. Dr.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duramesh

Device

Laparotomy closure with Duramesh

Polydioxanone suture

Device

Laparotomy closure with standard PDS

Primary outcomes

  1. The primary outcome is SSE that occurs within 1 month after surgery.

    Time frame: 1 month

    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

Secondary outcomes

  1. SSE within the first 12 months after repair.

    Time frame: 12 months

    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

  2. Clinical hernia occurrence/recurrence within 12 months after repair.

    Time frame: 12 months

    This study is intended to demonstrate Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.

  3. Return to the operating room (re-interventions) within 12 months for device related issue.

    Time frame: 12 months

    Re-interventions are defined as: All re-interventions relating to abdominal wall closure complications or abdominal re-exploration.

  4. Surgeon satisfaction at index-procedure using the 5-point smiley face scale.

    Time frame: Procedure

  5. Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.

    Time frame: 1 month

  6. Technical success of index-procedure.

    Time frame: Procedure

    Technical success is defined as successful abdominal wall closure without unexpected difficulties.

  7. Device performance using the 5-point smiley face scale.

    Time frame: Procedure

  8. Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.

    Time frame: 1 month

    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.

  9. Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.

    Time frame: 12 months

    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.

  10. Palpability/sensation of suture used for the repair at 12-months follow-up.

    Time frame: 12 months

    Assessment whether the patient can feel the suture.

  11. Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.

    Time frame: 12 months

    The SF-12 Health Survey is a 12-item, patient-reported survey of patient health.

  12. Patient satisfaction at 1-month follow-up 5-point smiley face scale.

    Time frame: 1 month

  13. Patient satisfaction at 12-months follow-up 5-point smiley face scale.

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Dorien Haesen, PhD

CONTACT

[email protected]

+32 11 28 69 48

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: MOMENTUM RCT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2023
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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