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Influence of Suture Type on Emergency Midline Laparotomy Closure

ConditionsLinea Alba HerniaEvisceration; Operation WoundSuture; Complications, Mechanical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital San Juan de Dios Tenerife

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

<18 years old, previous midline laparotomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • PDS 2/0 vs Monomax 2/0

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PDSActive comparator 1 intervention
Group B: MonomaxExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evisceration

Rate of evisceration

Time frame
1 month

Secondary outcomes

1

Wound complication

Seroma, hematoma, infection

Time frame
1 month
2

Incisional hernia

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

Time frame
1 year

Other outcomes

Sponsors and contacts

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Hospital San Juan de Dios Tenerife

Lead sponsor

University Hospital of the Nuestra Señora de Candelaria

Sponsor institution

Source ClinicalTrials.gov
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