PDS*Plus and Wound Infections After Laparotomy

Not Applicable

Completed

• Conditions: Wound Infection; Incisional Hernia
• Interventions: Device: PDS II; Device: PDS plus

• Registration Number: NCT00998907
• Lead Sponsor: University Hospital, Saarland

Brief Summary

The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound infections and incisional hernia after midline and transverse laparotomy comparing to polyglactin 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 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. In the first time period , the CP step for fascia closure foresees a triclosan-coated PDS 910 loop suture (PDS plus®, Ethicon GmbH, Norderstedt, Germany). In the second time period the CP step will be altered to the use of PDS loop suture (PDS II®, Ethicon GmbH, Norderstedt, Germany). The CP- step is changed every 100 patients to cluster-randomize the patients. The primary outcome is the number of wound infections. Together with this the number of incisional hernia will be recorded. 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: 2009-09
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2011-11
• Status Verified: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1042

Inclusion Criteria

• surgical pathologies accessed via midline or transverse abdominal incision
• primary fascial closure

Exclusion Criteria

• pregnancy
• age under 18 years
• open abdominal treatment
• known hypersensitivity against PDS/Triclosan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDS II	PDS II	PDS II® loop suture is used for abdominal wall closure
PDS plus	PDS plus	antibacterial coated "PDS plus" is used for abdominal wall closure

Primary Outcome Measures

Name	Time	Method
The number of wound infections	30 days after the operation

Secondary Outcome Measures

Name	Time	Method
The number of incisional hernias.	6 month
The number of incisional hernia- long time follow up	12 month	number of incisional hernia after 24 month

Trial Locations

Locations (1)

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