Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-03-31

Brief Summary

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Patients will be randomized 3 groups:

Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture

Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture

Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture

Incisional surgical.site infection and evisceration will be recorded.

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Detailed Description

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Patients will be randomized 3 groups:

Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture (Stratafix Symmetric, J\&J), caliber 1, 48mm-cylindric needle.

Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.

Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.

Incisional surgical.site infection and evisceration will be recorded.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patient and the epidemiology nurse, who will assess the presence of SSI, will be blinded to the treatment assigned.

The surgeon is masked to the assignment prior to consenting and enrolling the patient and initiating the surgery.

Study Groups

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Triclosan-coated barbed suture

Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture

Group Type EXPERIMENTAL

Triclosan-coated barbed suture

Intervention Type COMBINATION_PRODUCT

Use of Triclosan-coated Polydioxanone barbed suture

Triclosan-coated monofilament suture

Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture

Group Type EXPERIMENTAL

Triclosan-coated monofilament suture

Intervention Type COMBINATION_PRODUCT

Use of Triclosan-coated Polydioxanone monofilament suture

Monofilament suture

Abdominal wall closure will be performed using a monofilament suture

Group Type SHAM_COMPARATOR

Monofilament suture

Intervention Type DEVICE

Use of Polydioxanone monofilament suture

Interventions

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Triclosan-coated barbed suture

Use of Triclosan-coated Polydioxanone barbed suture

Intervention Type COMBINATION_PRODUCT

Triclosan-coated monofilament suture

Use of Triclosan-coated Polydioxanone monofilament suture

Intervention Type COMBINATION_PRODUCT

Monofilament suture

Use of Polydioxanone monofilament suture

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Contaminated and Dirty surgery
* Emergency surgery performed by midline laparotomic approach
* The following diagnosis will be included:

* Anastomotic leak of previous digestive surgery (colon, small bowel or gastric surgery)
* Colonic or bowel perforations
* Appendicitis with purulent of fecal peritonitis, undergoing midline laparotomy
* Perforation of gastric or duodenal ulcer
* Intestinal ischemia requiring bowel resection

Exclusion Criteria

* Emergency surgery undergoing laparoscopic approach
* Appendicitis operated by McBurney incision
* Intestinal isquemia without requiring bowel resection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No