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OpenTrials
Completed

NCT Number: NCT03763279

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

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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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital Elche

Elche, Alicante, 03203, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Triclosan-coated barbed suture

Combination Product

Use of Triclosan-coated Polydioxanone barbed suture

Triclosan-coated monofilament suture

Combination Product

Use of Triclosan-coated Polydioxanone monofilament suture

Monofilament suture

Device

Use of Polydioxanone monofilament suture

Primary outcomes

  1. Rate of incisional surgical-site infection

    Time frame: 30 days postoperatively

    Diagnosis of incisional surgical-site infection during the postoperative course

Secondary outcomes

  1. Rate of Evisceration

    Time frame: 30 days postoperatively

    Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2018
Registry last updated
Sep 16, 2019

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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