NCT01620294

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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 10, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

May 10, 2010

Last Update Submit

June 14, 2012

Conditions

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)

triclosan

EXPERIMENTAL

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

Procedure: abdominal wall closure

uncoated

EXPERIMENTAL

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

Procedure: surgical site infection

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
triclosan
surgical site infectionPROCEDURE

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
uncoated

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 malignant 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 unprepared 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery Medical Faculty, University of Pecs, Hungary

Pécs, 7624, 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: 10219875BACKGROUND

  • 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: 18636300BACKGROUND

  • 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: 18560962BACKGROUND

  • 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: 18338205BACKGROUND

  • 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: 15855756BACKGROUND

  • 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: 12573039BACKGROUND

  • 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: 17588420BACKGROUND

  • 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: 19231586BACKGROUND

MeSH Terms

Conditions

InfectionsSurgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative 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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2010

First Posted

June 15, 2012

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

November 1, 2010

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

HU(1)