Overview

This trial is active, not recruiting.

Condition wound infection
Treatment abdominal wall closure
Phase phase 2
Sponsor University of Pecs
Start date November 2009
End date April 2010
Trial size 1 participant
Trial identifier NCT01123616, triclosan-coated-suture

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
abdominal wall closure presence of surgical site infection
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
(Active Comparator)
Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
abdominal wall closure presence of surgical site infection
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall

Primary Outcomes

Measure
quality and quantity of wound discharge
time frame: 30 days

Secondary Outcomes

Measure
number of applied different types of bandages
time frame: 30 days
charges of wound care
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Elective (subjected to bowel preparation) operations - Benign or malignsnt colon or rectal disease - Age: 18-80 - Bowel opening is made during operation Exclusion Criteria: 1. Cannot be randomized: Systemic diseases influencing local surgical site healing Insulin-dependent diabetes mellitus Child B-C liver cirrhosis Kidney disease requiring dialysis Immune-suppression treatment IBD Acute surgery or unpreparated bowel After being informed patient does not sign the statement of consent 2. To be excluded later: Surgically incurable tumour Septic state or complication occurred in the post-operational stage Patient withdraws the signed consent before the examination is closed 3. Undesirable complication: Sterile surgical site separation Suture break during the post-operational stage

Additional Information

Official title Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material
Principal investigator Ors Peter Horvath, MD, PhD, DSc
Description After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of our 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. 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 materia which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation. attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the ID pannel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events - complications - control examination
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by University of Pecs.