PDS*Plus and Wound Infections After Laparotomy

Wound Infection Clinical Trial

— PDS*plus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998907
• Other study ID #: 09/2009
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: January 17, 2012
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1042
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incisional Hernia
• Infection
• Wound Infection

Intervention

Device:
• PDS plus
triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
• PDS II
polyglactin 910 suture material for abdominal wall closure

Locations

Country	Name	City	State
Germany	Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,	Homburg/Saar

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Justinger C, Moussavian MR, Schlueter C, Kopp B, Kollmar O, Schilling MK. Antibacterial [corrected] coating of abdominal closure sutures and wound infection. Surgery. 2009 Mar;145(3):330-4. doi: 10.1016/j.surg.2008.11.007. Epub 2009 Jan 25. Erratum in: Surgery. 2009 Sep;146(3):468. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of wound infections		30 days after the operation	No
Secondary	The number of incisional hernias.		6 month	No
Secondary	The number of incisional hernia- long time follow up	number of incisional hernia after 24 month	12 month	No