Antiseptic Sutures and Wound Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Justinger, University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00932503
First received: July 1, 2009
Last updated: June 13, 2012
Last verified: June 2012
  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.


Condition Intervention
Wound Infection
Device: Vicryl plus

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

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 ]

Secondary Outcome Measures:
  • The secondary outcome was the number of incisional hernia [ Time Frame: follow up points: 6 month, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]
    long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II


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
No Intervention: PDS II
PDS II® loop suture was used for abdominal wall closure
Active Comparator: Vicryl plus
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)
Other Name: Vicryl 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 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.

  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
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: 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: Christoph Justinger, Christoph Justinger, MDDepartment of General, Visceral, Vascular, and Pediatric Surgery, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT00932503     History of Changes
Other Study ID Numbers: Vicryl plus 1
Study First Received: July 1, 2009
Last Updated: June 13, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on October 23, 2014