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Completed

NCT Number: NCT00932503

Antiseptic Sutures and Wound Infection

The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon suture.

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Key information

Conditions

Wound Infection Infections

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, D-66421 Homburg/Saar, Germany

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 by a two-layer technique 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 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. 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 transverse abdominal incision
  • primary fascial closure

Exclusion criteria

  • pregnancy
  • age under 18 years
  • open abdominal treatment
  • known hypersensitivity agains PDS/Vicryl/Triclosan

Treatment and study plan

Vicryl plus

Device

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

Other names: Vicryl plus®

Primary outcomes

  1. The primary outcome was the number of wound infections.

    Time frame: 10 days after demission of patient from hospital

Secondary outcomes

  1. The secondary outcome was the number of incisional hernia

    Time frame: follow up points: 6 month, 1 year, 2 years and 3 years

    long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Official study title

Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jul 3, 2009
Registry last updated
Jun 14, 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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