Abdominal Wall Closure With Triclosan-coated Suture (TCS09)

University of Pecs

Status and phase: Completed; Phase 3

Conditions: Infection

Treatments: Procedure: abdominal wall closure; Procedure: surgical site infection

Study type: Interventional

Funder types: Other

Identifiers

NCT01620294

triclosan-coated-suture2009

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

triclosan

Experimental group

Description:

Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).

Treatment:

Procedure: abdominal wall closure

uncoated

Experimental group

Description:

Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).

Treatment:

Procedure: surgical site infection