Abdominal Wall Closure With Triclosan-coated Suture (TCS09-10)
NCT ID: NCT01123616
Last Updated: 2010-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
1 participants
INTERVENTIONAL
2009-11-30
2010-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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).
abdominal wall closure
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
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).
abdominal wall closure
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Interventions
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abdominal wall closure
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Benign or malignsnt colon or rectal disease
* Age: 18-80
* Bowel opening is made during operation
Exclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
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University of Pecs
OTHER
Responsible Party
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Prof. O P Horvath MD, PhD.ScD
Principal Investigators
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Ors Peter Horvath, MD, PhD, DSc
Role: PRINCIPAL_INVESTIGATOR
Head of Surg. Dept. Univ. of Pecs, Hungary - [email protected]
Locations
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Department of Surgery Medical Faculty, University of Pecs, Hungary
Pécs, , Hungary
Countries
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References
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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.
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.
Other Identifiers
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triclosan-coated-suture
Identifier Type: -
Identifier Source: org_study_id
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