NCT01123616

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

5 months

First QC Date

May 12, 2010

Last Update Submit

May 12, 2010

Conditions

Wound Infection

Keywords

surgical site infectionelective colorectal surgerylevel of surgical site infectioncomplication of surgical site infectiontype of changed bandagefrequency of bandage changing

Outcome Measures

Primary Outcomes (1)

  • quality and quantity of wound discharge

    30 days

Secondary Outcomes (2)

  • number of applied different types of bandages

    30 days

  • charges of wound care

    30 days

Study Arms (2)

non-triclosan-coated

ACTIVE COMPARATOR

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 suture

ACTIVE COMPARATOR

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

Interventions

abdominal wall closurePROCEDURE

triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall

Also known as: presence of surgical site infection, level of surgical site infection
non-triclosan-coatedtriclosan coated suture

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective (subjected to bowel preparation) operations
  • Benign or malignsnt colon or rectal disease
  • Age: 18-80
  • Bowel opening is made during operation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery Medical Faculty, University of Pecs, Hungary

Pécs, Hungary

Location

Related Publications (8)

  • 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.

    PMID: 10219875RESULT

  • 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.

    PMID: 18636300RESULT

  • 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.

    PMID: 18560962RESULT

  • 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.

    PMID: 18338205RESULT

  • 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.

    PMID: 15855756RESULT

  • 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.

    PMID: 12573039RESULT

  • 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.

    PMID: 17588420RESULT

  • 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.

    PMID: 19231586RESULT

MeSH Terms

Conditions

Wound InfectionSurgical Wound Infection

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ors Peter Horvath, MD, PhD, DSc

    Head of Surg. Dept. Univ. of Pecs, Hungary - ophorvath@iseb.pote.hu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 14, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

June 1, 2010

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations

HU(1)