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Completed

NCT Number: NCT00998907

PDS*Plus and Wound Infections After Laparotomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,

Homburg/Saar, D-66421, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDS plus

Device

triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)

Other names: PDS plus®

PDS II

Device

polyglactin 910 suture material for abdominal wall closure

Primary outcomes

  1. The number of wound infections

    Time frame: 30 days after the operation

Secondary outcomes

  1. The number of incisional hernias.

    Time frame: 6 month

  2. The number of incisional hernia- long time follow up

    Time frame: 12 month

    number of incisional hernia after 24 month

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Official study title

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

Acronym: PDS*plus

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 21, 2009
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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