Clinical Outcome in View of Surgical Site Infection (SSI) With Antibacterial Skin Sutures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01540279
First received: February 22, 2012
Last updated: February 27, 2012
Last verified: February 2012

February 22, 2012
February 27, 2012
July 2011
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Complete list of historical versions of study NCT01540279 on ClinicalTrials.gov Archive Site
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Clinical Outcome in View of Surgical Site Infection (SSI) With Antibacterial Skin Sutures
Do Antibacterial Skin Sutures Reduce Surgical Site Infections After Open Abdominal Surgery?

Background: Poor wound healing and the development of surgical site infection (SSI) continue to occur and remain a significant cause of disability among operated patients. In spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common complications in conventional abdominal surgery with an incidence in the literature between 4% and 17%. As it is known that surgical sutures potentiate the development of wound infection the search for an ideal suture material, suitable for all purposes has been pursued by surgeons for decades.

Hypothesis: In line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after open abdominal surgery Methods: To prevent microbial colonization of suture material in operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture materials with antibacterial activity will be tested against un-coated suture material for skin closure after open abdominal surgery of 200 patients. The study is planed as a single center, randomized controlled trial. After ethical approval the patients will be consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to detect and document wound complications. Wound complications will be classified according to Center for Disease Control and Prevention Standard guidelines. Data will be collected and the rate of SSI will be analysed in both groups.

Expected value of the proposed project: If the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower SSI after open abdominal surgery and might be also used in other surgical fields. By lowering the rate of SSI the investigators might offer a new and cost saving procedure to the surgical community.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

All patients with required open abdominal surgery will be consecutively enrolled.Data of emergency patients are recorded separately as well as patients with a contaminated or dirty-infected (class III-IV) operative wound classified according to CDC guidelines on surgical wound classification1 further Patients with implanted foreign material such as mesh or vascular prosthesis.

Wound Infection, Surgical
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  • Cohort one with abdominal wall closure with Monocryl
  • Cohort two with abdominal wall closure with Monocryl plus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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Inclusion Criteria:

  • All patients from the Visceral Department of Basel University Hospital requiring open abdominal surgery. Open abdominal surgery is defined as: opened peritoneal cavity

Exclusion Criteria:

  • factors limiting the ability to co-operate in the study;
  • absence of signed informed consent before entering the study;
  • people with mental disorders;
  • pregnant women;
  • participants under 18 years
Both
18 Years and older
No
Contact: Heidi Misteli, MD 0041612652525 mistelih@uhbs.ch
Contact: Philipp Kirchhoff, MD 0041612652525 kirchhoffp@uhbs.ch
Switzerland
 
NCT01540279
University Hospital Basel
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University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
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Study Chair: Heidi Misteli, MD Surgical Department of University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP