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Abdominal Wall Closure With Triclosan-coated Suture (TCS09-10)

NCT01123616 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2010-05-14

No results posted yet for this study

Summary

After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.

Conditions

  • Wound Infection

Interventions

PROCEDURE

abdominal wall closure

triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Principal Investigators

  • Ors Peter Horvath, MD, PhD, DSc · Head of Surg. Dept. Univ. of Pecs, Hungary - [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2010-06-30

Countries

  • Hungary

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123616 on ClinicalTrials.gov