Antiseptic Sutures and Wound Infection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
All patients are 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 is achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. Patients demographic and disease as well as procedure related data are 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), are collected prospectively to compare the two groups.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: PDS II PDS II® loop suture was used for abdominal wall closure |
|
| Active Comparator: Vicryl plus antiseptic coated "Vicryl plus" was used for abdominal wall closure |
Device: Vicryl plus
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)
Other Names:
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Outcome Measures
Primary Outcome Measures
- The primary outcome was the number of wound infections. [10 days after demission of patient from hospital]
Secondary Outcome Measures
- The secondary outcome was the number of incisional hernia [follow up points: 6 month, 1 year, 2 years and 3 years]
long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II
Eligibility Criteria
Criteria
Inclusion Criteria:
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surgical pathologies accessed via transverse abdominal incision
-
primary fascial closure
Exclusion Criteria:
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pregnancy
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age under 18 years
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open abdominal treatment
-
known hypersensitivity agains PDS/Vicryl/Triclosan
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany | Homburg/Saar | Germany | D-66421 |
Sponsors and Collaborators
- University Hospital, Saarland
Investigators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- Vicryl plus 1