Antiseptic Sutures and Wound Infection
Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.
1 other identifier
interventional
839
1 country
1
Brief Summary
The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon suture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2003
Longer than P75 for not_applicable
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
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 3, 2009
CompletedJune 14, 2012
June 1, 2012
4 years
July 1, 2009
June 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome was the number of wound infections.
10 days after demission of patient from hospital
Secondary Outcomes (1)
The secondary outcome was the number of incisional hernia
follow up points: 6 month, 1 year, 2 years and 3 years
Study Arms (2)
PDS II
NO INTERVENTIONPDS II® loop suture was used for abdominal wall closure
Vicryl plus
ACTIVE COMPARATORantiseptic coated "Vicryl plus" was used for abdominal wall closure
Interventions
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)
Eligibility Criteria
You may qualify if:
- surgical pathologies accessed via transverse abdominal incision
- primary fascial closure
You may not qualify if:
- pregnancy
- age under 18 years
- open abdominal treatment
- known hypersensitivity agains PDS/Vicryl/Triclosan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Homburg/Saar, D-66421, Germany
Related Publications (1)
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Justinger, M.D.
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
- STUDY DIRECTOR
Martin K Schilling, M.D.
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Christoph Justinger, MDDepartment of General, Visceral, Vascular, and Pediatric Surgery
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 3, 2009
Study Start
October 1, 2003
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
June 14, 2012
Record last verified: 2012-06