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

January 17, 2012 updated by: Christoph Justinger, University Hospital, Saarland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1042

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg/Saar, Germany, D-66421
        • Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • PDS plus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of wound infections
Time Frame: 30 days after the operation
30 days after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of incisional hernias.
Time Frame: 6 month
6 month
The number of incisional hernia- long time follow up
Time Frame: 12 month
number of incisional hernia after 24 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Study Director: Martin K Schilling, M.D., FRCS, Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (ESTIMATE)

October 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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