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Completed

NCT Number: NCT01620294

Abdominal Wall Closure With Triclosan-coated Suture

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Surgery Medical Faculty, University of Pecs, Hungary

Pécs, 7624, Hungary

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • 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
  • Undesirable complication:
  • Sterile surgical site separation
  • Suture break during the post-operational stage

Treatment and study plan

abdominal wall closure

Procedure

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

Other names: presence of surgical site infection, level of surgical site infection

surgical site infection

Procedure

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

Other names: presence of surgical site infection, level of surgical site infection

Primary outcomes

  1. quality and quantity of wound discharge

    Time frame: 30 days

Secondary outcomes

  1. number of applied different types of bandages

    Time frame: 30 days

  2. charges of wound care

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Acronym: TCS09

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 15, 2012
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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