Abdominal Wall Closure With Triclosan-coated Suture

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620294

Acronym

TCS09

Enrollment

Registered

2012-06-15

Start date

2009-11-30

Completion date

2010-11-30

Last updated

2012-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

surgical site infection, elective colorectal surgery, level of surgical site infection, complication of surgical site infection, type of changed bandage, frequency of bandage changing

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

Interventions

PROCEDUREabdominal wall closure

triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall

PROCEDUREsurgical site infection

triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
quality and quantity of wound discharge	30 days

Secondary

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

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026