Clinical trial NCT01620294: Abdominal Wall Closure With Triclosan-coated Suture
Official title: Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: quality and quantity of wound discharge
timeFrame: 30 days
Secondary outcomes:
measure: number of applied different types of bandages
timeFrame: 30 days
measure: charges of wound care
timeFrame: 30 days
Other outcomes:
Locations:
city: Pecs
country: Hungary
facility: Department of Surgery Medical Faculty, University of Pecs, Hungary
Study officials:
affiliation: Head of Surg.Dept. Univ. of Pecs, Hungary - ophorvath@iseb.pote.hu
name: Ors Peter Horvath, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.