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

Study Overview
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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.

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.

Official Title
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Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Combination Product: Triclosan-coated barbed suture
* Combination Product: Triclosan-coated monofilament suture
* Device: Monofilament suture


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triclosan-coated barbed suture<br>Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture | Combination Product: Triclosan-coated barbed suture<br>* Use of Triclosan-coated Polydioxanone barbed suture<br>|
| Experimental: Triclosan-coated monofilament suture<br>Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture | Combination Product: Triclosan-coated monofilament suture<br>* Use of Triclosan-coated Polydioxanone monofilament suture<br>|
| Sham Comparator: Monofilament suture<br>Abdominal wall closure will be performed using a monofilament suture | Device: Monofilament suture<br>* Use of Polydioxanone monofilament suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of incisional surgical-site infection | Diagnosis of incisional surgical-site infection during the postoperative course | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Evisceration | Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination | 30 days postoperatively |