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Sponsored by: |
University Hospital, Saarland |
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Information provided by: | University Hospital, Saarland |
ClinicalTrials.gov Identifier: | NCT00932503 |
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. Between 10/03 and 10/07, 839 operations were performed using a transverse abdominal incision. In the first time period (TP1), a PDS II® loop suture was used for abdominal wall closure. In the second time period (TP2), we used Vicryl plus®. Risk factors for poor wound healing were collected prospectively to compare the two groups. The primary outcome was the number of wound infections. All patients were treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre.
Condition | Intervention |
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Wound Infection Open Abdominal Surgery Fascial Closure |
Device: Vicryl plus |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Crossover Assignment |
Official Title: | Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study. |
Enrollment: | 839 |
Study Start Date: | October 2003 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PDS II: No Intervention
PDS II® loop suture was used for abdominal wall closure
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Vicryl plus: Active Comparator
antiseptic coated "Vicryl plus" was used for abdominal wall closure
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Device: Vicryl plus
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)
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In our Department 839 operations were performed using a transverse abdominal incision between 10/03 and 10/07.
All patients were treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure. Wound closure was achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio was at least 4:1. The running sutures were 1 cm apart and at least 1.5 cm from the wound edge 14. In the time between October 2003 and September 2005 (time period one, TP1), the CP step for fascia closure foresaw a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). In October 2005, that CP step was altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome was the number of wound infections. Patients demographic and disease as well as procedure related data were collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), were collected prospectively to compare the two groups.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany | |
Homburg/Saar, Germany, D-66421 |
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 |
Responsible Party: | Department of General, Visceral, Vascular, and Pediatric Surgery ( Martin K. Schilling MD, FRCS ) |
Study ID Numbers: | Vicryl plus 1 |
Study First Received: | July 1, 2009 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00932503 History of Changes |
Health Authority: | Germany: Ethics Commission |
Vicryl plus wound infection coated suture material open abdominal surgery transverse laparotomy |
Anti-Infective Agents Anti-Infective Agents, Local Hexachlorophene Wounds and Injuries |
Disorders of Environmental Origin Triclosan Wound Infection |
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Therapeutic Uses Wounds and Injuries |
Disorders of Environmental Origin Infection Pharmacologic Actions Wound Infection |