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

University of Pecs

Status and phase: Unknown; Phase 2

Conditions: Wound Infection

Treatments: Procedure: abdominal wall closure

Study type: Interventional

Funder types: Other

Identifiers

NCT01123616

triclosan-coated-suture

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 estimated patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

non-triclosan-coated

Active Comparator group

Description:

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

Treatment:

Procedure: abdominal wall closure

triclosan coated suture

Active Comparator group

Description:

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

Treatment:

Procedure: abdominal wall closure