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

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

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.

Study Overview

• Status: Unknown
• Conditions: Wound Infection
• Intervention / Treatment: Procedure: abdominal wall closure

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

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Pecs, Hungary
    • Department of Surgery Medical Faculty, University of Pecs, Hungary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: non-triclosan-coated; Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).	Procedure: abdominal wall closure; 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
ACTIVE_COMPARATOR: triclosan coated suture; Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).	Procedure: abdominal wall closure; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quality and quantity of wound discharge	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Principal Investigator: Ors Peter Horvath, MD, PhD, DSc, Head of Surg. Dept. Univ. of Pecs, Hungary - ophorvath@iseb.pote.hu

Publications and helpful links

General Publications

• Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
• Nishikawa K, Hanyuu N, Yuda M, Tanaka Y, Matsumoto A, Yasue H, Hayashi T, Kawano S, Usuba T, Iino T, Mizuno R, Iwabuchi S. How can we control intraoperative bacterial contamination and surgical-site infection during an anterior resection or Hartmann's/Miles' operation? J Gastrointest Surg. 2008 Nov;12(11):1995-2000. doi: 10.1007/s11605-008-0582-z. Epub 2008 Jul 18.
• Watanabe A, Kohnoe S, Shimabukuro R, Yamanaka T, Iso Y, Baba H, Higashi H, Orita H, Emi Y, Takahashi I, Korenaga D, Maehara Y. Risk factors associated with surgical site infection in upper and lower gastrointestinal surgery. Surg Today. 2008;38(5):404-12. doi: 10.1007/s00595-007-3637-y. Epub 2008 Apr 30.
• Kobayashi M, Mohri Y, Inoue Y, Okita Y, Miki C, Kusunoki M. Continuous follow-up of surgical site infections for 30 days after colorectal surgery. World J Surg. 2008 Jun;32(6):1142-6. doi: 10.1007/s00268-008-9536-6.
• Nichols RL, Choe EU, Weldon CB. Mechanical and antibacterial bowel preparation in colon and rectal surgery. Chemotherapy. 2005;51 Suppl 1:115-21. doi: 10.1159/000081998.
• Barbolt TA. Chemistry and safety of triclosan, and its use as an antimicrobial coating on Coated VICRYL* Plus Antibacterial Suture (coated polyglactin 910 suture with triclosan). Surg Infect (Larchmt). 2002;3 Suppl 1:S45-53. doi: 10.1089/sur.2002.3.s1-45.
• Fleck T, Moidl R, Blacky A, Fleck M, Wolner E, Grabenwoger M, Wisser W. Triclosan-coated sutures for the reduction of sternal wound infections: economic considerations. Ann Thorac Surg. 2007 Jul;84(1):232-6. doi: 10.1016/j.athoracsur.2007.03.045. Erratum In: Ann Thorac Surg. 2007 Dec;84(6):2139.
• Justinger C, Moussavian MR, Schlueter C, Kopp B, Kollmar O, Schilling MK. Antibacterial [corrected] coating of abdominal closure sutures and wound infection. Surgery. 2009 Mar;145(3):330-4. doi: 10.1016/j.surg.2008.11.007. Epub 2009 Jan 25. Erratum In: Surgery. 2009 Sep;146(3):468.

Helpful Links

• (website is in Hungarian, secured by an independent officer)

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ANTICIPATED): April 1, 2010
• Study Completion (ANTICIPATED): June 1, 2010

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (ESTIMATE): May 14, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2010
• Last Update Submitted That Met QC Criteria: May 12, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: triclosan-coated-suture