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

Primary Purpose

Wound Infection

Status
Unknown status
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
abdominal wall closure
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring surgical site infection, elective colorectal surgery, level of surgical site infection, complication of surgical site infection, type of changed bandage, frequency of bandage changing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

non-triclosan-coated

triclosan coated suture

Arm Description

Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).

Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).

Outcomes

Primary Outcome Measures

quality and quantity of wound discharge

Secondary Outcome Measures

number of applied different types of bandages
charges of wound care

Full Information

First Posted
May 12, 2010
Last Updated
May 12, 2010
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT01123616
Brief Title
Abdominal Wall Closure With Triclosan-coated Suture (TCS09-10)
Official Title
Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pecs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound 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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-triclosan-coated
Arm Type
Active Comparator
Arm Description
Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
Arm Title
triclosan coated suture
Arm Type
Active Comparator
Arm Description
Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
Intervention Type
Procedure
Intervention Name(s)
abdominal wall closure
Other Intervention Name(s)
presence of surgical site infection, level of surgical site infection
Intervention Description
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Primary Outcome Measure Information:
Title
quality and quantity of wound discharge
Time Frame
30 days
Secondary Outcome Measure Information:
Title
number of applied different types of bandages
Time Frame
30 days
Title
charges of wound care
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ors Peter Horvath, MD, PhD, DSc
Organizational Affiliation
Head of Surg. Dept. Univ. of Pecs, Hungary - ophorvath@iseb.pote.hu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery Medical Faculty, University of Pecs, Hungary
City
Pecs
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
10219875
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.
Results Reference
result
PubMed Identifier
18636300
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.
Results Reference
result
PubMed Identifier
18560962
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.
Results Reference
result
PubMed Identifier
18338205
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.
Results Reference
result
PubMed Identifier
15855756
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.
Results Reference
result
PubMed Identifier
12573039
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.
Results Reference
result
PubMed Identifier
17588420
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. Erratum In: Ann Thorac Surg. 2007 Dec;84(6):2139.
Results Reference
result
PubMed Identifier
19231586
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. Erratum In: Surgery. 2009 Sep;146(3):468.
Results Reference
result

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

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