Clinical trial NCT00998907: PDS*Plus and Wound Infections After Laparotomy
Official title: Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Incisional Hernia
Keywords: Open Abdominal Surgery
Fascial Closure
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2009-10-21
Enrollment: 1042
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of wound infections
timeFrame: 30 days after the operation
Secondary outcomes:
measure: The number of incisional hernias.
timeFrame: 6 month
measure: The number of incisional hernia- long time follow up
timeFrame: 12 month
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,
Study officials:
affiliation: Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
name: Christoph Justinger, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
name: Martin K Schilling, M.D., FRCS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Justinger C, Slotta JE, Ningel S, Graber S, Kollmar O, Schilling MK. Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery. 2013 Sep;154(3):589-95. doi: 10.1016/j.surg.2013.04.011. Epub 2013 Jul 13.