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NCT Number: NCT06865807

Influence of Suture Type on Emergency Midline Laparotomy Closure

There is no clear recommendation in international guidelines regarding the type of suture to be used for closing emergency midline laparotomies. It is recommended to follow the same principles as in elective surgery, thus performing the closure with a continuous suture of slowly absorbable monofilament 2-0 with small-bites technique. Currently, there are several slowly absorbable sutures available on the market, and our center uses two: PDS® and Monomax®. These two sutures are currently used interchangeably at our institution based on the preferences of each surgeon.

Objective: study whether there are differences between these two sutures in the closure of emergency midline laparotomy.

Recruiting

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Key information

Conditions

Linea Alba Hernia Evisceration; Operation Wound Suture; Complications, Mechanical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

Location status: Recruiting

Location contact

Julen Ramón, PhD

CONTACT

[email protected]

672255215

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >18 years old, patients undergoing emergency midline laparotomy by the General Surgery Department.

Exclusion criteria

  • <18 years old, previous midline laparotomy

Treatment and study plan

PDS 2/0 vs Monomax 2/0

Procedure

We will include in the study patients who require an emergency midline laparotomy by the General and Digestive Surgery Department of the University Hospital Nuestra Señora de Candelaria. Patients will be randomized based on their medical record number: those with an even number will undergo laparotomy closure using PDS 2/0, and those with an odd number will receive Monomax 2/0.

Primary outcomes

  1. Evisceration

    Time frame: 1 month

    Rate of evisceration

Secondary outcomes

  1. Wound complication

    Time frame: 1 month

    Seroma, hematoma, infection

  2. Incisional hernia

    Time frame: 1 year

    Evaluate the rate of incisional hernia during follow-up in outpatient consultations.

Sponsors and collaborators

Lead sponsor

Hospital San Juan de Dios Tenerife

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 11, 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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