NCT00998907

PDS*Plus and Wound Infections After Laparotomy

Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,042 (actual)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Infection
• Incisional Hernia

Interventions

Type	Name	Description
DEVICE	PDS plus	triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
DEVICE	PDS II	polyglactin 910 suture material for abdominal wall closure

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-11-01
• Completion: 2012-01-01
• First posted: 2009-10-21
• Last updated: 2012-01-18

Locations

1 site across 1 country: Germany