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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540279
Recruitment Status : Terminated (insufficient enrollment)
First Posted : February 28, 2012
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

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.

Condition or disease
Wound Infection, Surgical

Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Do Antibacterial Skin Sutures Reduce Surgical Site Infections After Open Abdominal Surgery?
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Cohort one with abdominal wall closure with Monocryl
Cohort two with abdominal wall closure with Monocryl plus

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540279

Surgical Department of University Hospital Basel, Switzerland
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Study Chair: Heidi Misteli, MD Surgical Department of University Hospital Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01540279     History of Changes
Other Study ID Numbers: University Hospital Basel
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents