Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
2 other identifiers
interventional
279
1 country
1
Brief Summary
Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors, surgical site infections (SSI) remain the most frequent complication of colorectal resection (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of local antimicrobial agents seems successful. The primary aim of the present trial was to evaluate the efficacy of a surgical suture, coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after colorectal operations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedJune 5, 2013
May 1, 2013
3.8 years
May 24, 2013
May 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of surgical site infection
the incidence of superficial and deep wound infection in patients who underwent colorectal resection will be determined by a blind observer according to the Atlanta CDC definition. The unit of measure will be number of wound infection over the number of treated or control patients
30 days
Secondary Outcomes (1)
overall wound complications
30 days
Other Outcomes (1)
length of hospital stay
30 days
Study Arms (2)
control
ACTIVE COMPARATORregular suture not coated with triclosan
triclosan
EXPERIMENTALExperimental group will receive abdominal wound closure with suture matherial that is coated with triclosan
Interventions
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
The control arm will have the abdominal wound sutured with a regular non-coated suture
Eligibility Criteria
You may qualify if:
- patients candidate to elective colorectal resection
You may not qualify if:
- no consent
- peritonitis
- hypersensitivity to triclosan
- ASA \> 3
- ongoing infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Gerardo Hospital
Monza, 20900, Italy
Related Publications (1)
Chang WK, Srinivasa S, Morton R, Hill AG. Triclosan-impregnated sutures to decrease surgical site infections: systematic review and meta-analysis of randomized trials. Ann Surg. 2012 May;255(5):854-9. doi: 10.1097/SLA.0b013e31824e7005.
PMID: 22470067BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Angelo Nespoli, MD
Milano-Bicocca University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
May 24, 2013
First Posted
June 5, 2013
Study Start
May 1, 2009
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
June 5, 2013
Record last verified: 2013-05