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Antiseptic Sutures and Wound Infection
This study has been completed.
First Received: July 1, 2009   No Changes Posted
Sponsored by: University Hospital, Saarland
Information provided by: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT00932503
  Purpose

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. Between 10/03 and 10/07, 839 operations were performed using a transverse abdominal incision. In the first time period (TP1), a PDS II® loop suture was used for abdominal wall closure. In the second time period (TP2), we used Vicryl plus®. Risk factors for poor wound healing were collected prospectively to compare the two groups. The primary outcome was the number of wound infections. All patients were treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre.


Condition Intervention
Wound Infection
Open Abdominal Surgery
Fascial Closure
Device: Vicryl plus

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Crossover Assignment
Official Title: Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.

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Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • The primary outcome was the number of wound infections. [ Time Frame: 10 days after demission of patient from hospital ] [ Designated as safety issue: No ]

Enrollment: 839
Study Start Date: October 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PDS II: No Intervention
PDS II® loop suture was used for abdominal wall closure
Vicryl plus: Active Comparator
antiseptic coated "Vicryl plus" was used for abdominal wall closure
Device: Vicryl plus
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)

Detailed Description:

In our Department 839 operations were performed using a transverse abdominal incision between 10/03 and 10/07.

All patients were 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 was achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio was at least 4:1. The running sutures were 1 cm apart and at least 1.5 cm from the wound edge 14. In the time between October 2003 and September 2005 (time period one, TP1), the CP step for fascia closure foresaw a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). In October 2005, that CP step was altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome was the number of wound infections. Patients demographic and disease as well as procedure related data were 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), were 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 transverse abdominal incision
  • primary fascial closure

Exclusion Criteria:

  • pregnancy
  • age under 18 years
  • open abdominal treatment
  • known hypersensitivity agains PDS/Vicryl/Triclosan
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932503

Locations
Germany
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
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. Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
  More Information

Publications:
Responsible Party: Department of General, Visceral, Vascular, and Pediatric Surgery ( Martin K. Schilling MD, FRCS )
Study ID Numbers: Vicryl plus 1
Study First Received: July 1, 2009
Last Updated: July 1, 2009
ClinicalTrials.gov Identifier: NCT00932503     History of Changes
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Saarland:
Vicryl plus
wound infection
coated suture material
open abdominal surgery
transverse laparotomy

Study placed in the following topic categories:
Anti-Infective Agents
Anti-Infective Agents, Local
Hexachlorophene
Wounds and Injuries
Disorders of Environmental Origin
Triclosan
Wound Infection

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Communicable Diseases
Therapeutic Uses
Wounds and Injuries
Disorders of Environmental Origin
Infection
Pharmacologic Actions
Wound Infection

ClinicalTrials.gov processed this record on September 10, 2009