Abdominal Wall Closure With Triclosan-coated Suture

Phase 3

Completed

• Conditions: Infection
• Interventions: Procedure: surgical site infection; Procedure: abdominal wall closure

• Registration Number: NCT01620294
• Lead Sponsor: University of Pecs

Brief Summary

After open colorectal 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 separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus 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.

Detailed Description

After open colorectal 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 separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus). Triclosan is an antiseptic material 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 panel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events

* complications

* control examination

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-04
• Study First Submitted: 2010-05-10
• Study Completion: 2010-11
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-14
• Last Update Submitted: 2012-06-14
• Study First Posted: 2012-06-15
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Elective (subjected to bowel preparation) operations
• Benign or malignant 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 unprepared 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uncoated	surgical site infection	Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
triclosan	abdominal wall closure	Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).

Primary Outcome Measures

Name	Time	Method
quality and quantity of wound discharge	30 days

Secondary Outcome Measures

Name	Time	Method
charges of wound care	30 days
number of applied different types of bandages	30 days

Trial Locations

Locations (1)

Department of Surgery Medical Faculty, University of Pecs, Hungary; 🇭🇺 Pecs, Hungary