NCT03763279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

November 30, 2018

Last Update Submit

September 12, 2019

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • Rate of incisional surgical-site infection

    Diagnosis of incisional surgical-site infection during the postoperative course

    30 days postoperatively

Secondary Outcomes (1)

  • Rate of Evisceration

    30 days postoperatively

Study Arms (3)

Triclosan-coated barbed suture

EXPERIMENTAL

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

Combination Product: Triclosan-coated barbed suture

Triclosan-coated monofilament suture

EXPERIMENTAL

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

Combination Product: Triclosan-coated monofilament suture

Monofilament suture

SHAM COMPARATOR

Abdominal wall closure will be performed using a monofilament suture

Device: Monofilament suture

Interventions

Triclosan-coated barbed sutureCOMBINATION_PRODUCT

Use of Triclosan-coated Polydioxanone barbed suture

Triclosan-coated barbed suture
Triclosan-coated monofilament sutureCOMBINATION_PRODUCT

Use of Triclosan-coated Polydioxanone monofilament suture

Triclosan-coated monofilament suture
Monofilament sutureDEVICE

Use of Polydioxanone monofilament suture

Monofilament suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Elche

Elche, Alicante, 03203, Spain

Location

Related Publications (1)

  • 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.

    PMID: 32113031DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andres Garcia-Marin

    Hospital de San Juan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 4, 2018

Study Start

November 30, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

September 16, 2019

Record last verified: 2019-09

Locations

ES(1)