Antiseptic Sutures and Wound Infection
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Wound Infection |
Device: Vicryl plus |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study. |
- The primary outcome was the number of wound infections. [ Time Frame: 10 days after demission of patient from hospital ] [ Designated as safety issue: No ]
- The secondary outcome was the number of incisional hernia [ Time Frame: follow up points: 6 month, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II
| 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 |
|---|---|
|
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 Name: Vicryl plus®
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- surgical pathologies accessed via transverse abdominal incision
- primary fascial closure
Exclusion Criteria:
- pregnancy
- age under 18 years
- open abdominal treatment
- known hypersensitivity agains PDS/Vicryl/Triclosan
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | Christoph Justinger, Christoph Justinger, MDDepartment of General, Visceral, Vascular, and Pediatric Surgery, University Hospital, Saarland |
| ClinicalTrials.gov Identifier: | NCT00932503 History of Changes |
| Other Study ID Numbers: | Vicryl plus 1 |
| Study First Received: | July 1, 2009 |
| Last Updated: | June 13, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital, Saarland:
|
Vicryl plus wound infection coated suture material open abdominal surgery transverse laparotomy |
Additional relevant MeSH terms:
|
Wound Infection Infection Wounds and Injuries Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013