Wound Infection, Surgical Clinical Trial
Official title:
Do Antibacterial Skin Sutures Reduce Surgical Site Infections After Open Abdominal Surgery?
Verified date | March 2015 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 52 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Surgical Department of University Hospital Basel, Switzerland | Basel | Basel-Stadt |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
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