Antiseptic Sutures and Wound Infection

Not Applicable

Completed

• Conditions: Wound Infection
• Interventions: Device: Vicryl plus

• Registration Number: NCT00932503
• Lead Sponsor: University Hospital, Saarland

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.

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 Timeline

• Study Start: 2003-10
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 839

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vicryl plus	Vicryl plus	antiseptic coated "Vicryl plus" was used for abdominal wall closure

Primary Outcome Measures

Name	Time	Method
The primary outcome was the number of wound infections.	10 days after demission of patient from hospital

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany; 🇩🇪 Homburg/Saar, Germany