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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

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:

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

Sites / Locations

Department of Surgery Medical Faculty, University of Pecs, Hungary

Arms of the Study

Arm 1

Arm 2

Arm Type

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).

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

NCT ID

NCT01123616

First Posted

May 12, 2010

Last Updated

May 12, 2010

Sponsor

University of Pecs

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

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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