NCT02018289

Brief Summary

The abdominal closure with triclosan coated suture will reduce superficial surgical site infection.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
Last Updated

December 23, 2013

Status Verified

December 1, 2013

Enrollment Period

6.2 years

First QC Date

December 17, 2013

Last Update Submit

December 20, 2013

Conditions

Surgical Site Infection

Keywords

Triclosan coated sutureSurgical site infectionFecal peritonitisSuperficialincisional

Outcome Measures

Primary Outcomes (1)

  • Superficial surgical site infection (SSI)

    SSI will be evaluated in the postoperative course and up to 60 days after surgery

    60 postoperative days

Study Arms (2)

Triclosan

EXPERIMENTAL

Suture of the abdominal wall with triclosan coated suture

Procedure: Triclosan coated suture

No triclosan

SHAM COMPARATOR

Suture of the abdominal wall with the same suture, but without triclosan

Procedure: No triclosan

Interventions

Triclosan coated suturePROCEDURE

Suture of the abdominal wall with triclosan coated suture

Triclosan
No triclosanPROCEDURE

Suture of the abdominal wall with suture without triclosan coat

No triclosan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fecal peritonitis

You may not qualify if:

  • Perioperative mortality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital Elche

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Surgical Wound InfectionSurgical Wound

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Jaime Ruiz-Tovar, MD, PhD

    Hospital General Universitario de Elche

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 23, 2013

Study Start

October 1, 2007

Primary Completion

December 1, 2013

Last Updated

December 23, 2013

Record last verified: 2013-12

Locations

ES(1)