NCT01123616

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

Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: University of Pecs · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Wound Infection

Interventions

Type	Name	Description
PROCEDURE	abdominal wall closure	triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2010-05-14
• Last updated: 2010-05-14

Locations

1 site across 1 country: Hungary