PDS*Plus and Wound Infections After Laparotomy (PDS*plus)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Justinger, University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00998907
First received: October 20, 2009
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Wound Infection
Incisional Hernia
Device: PDS plus
Device: PDS II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • The number of wound infections [ Time Frame: 30 days after the operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of incisional hernias. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • The number of incisional hernia- long time follow up [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    number of incisional hernia after 24 month


Enrollment: 1042
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PDS II
PDS II® loop suture is used for abdominal wall closure
Device: PDS II
polyglactin 910 suture material for abdominal wall closure
Other Name: PDS II
Experimental: PDS plus
antibacterial coated "PDS plus" is used for abdominal wall closure
Device: PDS plus
triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
Other Name: PDS plus®

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998907

Locations
Germany
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,
Homburg/Saar, Germany, D-66421
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Christoph Justinger, M.D. Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Study Director: Martin K Schilling, M.D., FRCS Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Justinger, Priciple Investigator, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT00998907     History of Changes
Other Study ID Numbers: 09/2009
Study First Received: October 20, 2009
Last Updated: January 17, 2012
Health Authority: Germany: Ministry of Health

Keywords provided by University Hospital, Saarland:
Open Abdominal Surgery
Fascial Closure

Additional relevant MeSH terms:
Hernia
Wound Infection
Pathological Conditions, Anatomical
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014