Clinical trial NCT03763279: Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery
Official title: Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infection
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of incisional surgical-site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Rate of Evisceration
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Elche
country: Spain
facility: General Hospital Elche
state: Alicante
Study officials:
affiliation: Hospital de San Juan
name: Andres Garcia-Marin
role: STUDY_DIRECTOR
References:
citation: Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27.