Clinical trial NCT01007487: Plastic Wound Retractors and Bacterial Translocation in Abdominal Surgery
Official title: Wound Retractor or Protector? Efficacy of a Plastic Wound Retractor (Alexis®) in Impeding Translocation of Enteric Bacteria to the Surgical Incision Site in Abdominal Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Translocation
Surgical Site Infection
Abdominal Surgery
Wound Infection
Keywords: Plastic wound protector
Plastic wound retractor
Bacterial translocation
Surgical site infection
Abdominal surgery
Wound infection
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing abdominal surgery in which a plastic wound retractor is used.

Brief summary: Hypothesis: Plastic wound retractors reduce passage of bacteria from the abdomen to the surgical incision site in abdominal surgery

Currently, plastic wound retractors are used in abdominal surgery to facilitate access to the abdominal cavity. This study aims to establish whether they also prevent bacteria crossing from the abdominal cavity to the surgical incision site. Patients undergoing abdominal surgery in which a plastic wound retractor (Alexis®)is used are eligible for inclusion in the study. Swabs are taken from the inside and the outside of the plastic wound retractor prior to removing the retractor from the abdomen. The bacterial flora from swabs taken inside and outside the plastic wound protector are then compared to see if there is any difference between inside and outside the retractor. Bacteria are classified as 'enteric'(i.e. from the gastrointestinal tract) or 'skin' bacteria, depending on their usual location. The study aims to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric bacteria to the surgical incision site.

Detailed description: Plastic wound retractors are currently used in abdominal surgery for wound retraction. They allow access to intra-abdominal organs through an incision in abdominal surgery. Plastic wound retractors may also act as a barrier to bacterial translocation from the abdominal cavity to the wound. The purpose of this study was to compare microbial flora from inside and outside the plastic wound retractor to establish whether plastic wound retractors affect bacterial translocation.

METHODS This multi-centre prospective observational study is being conducted between November 2007 and January 2010. Patients undergoing elective or emergency abdominal surgery in which an Alexis® wound retractor is used are eligible for inclusion in the study. Swabs are taken from inside and outside the Alexis® wound protector immediately prior to removal of the wound protector from the abdominal cavity. Swabs undergo gram stain and culture. "Inside" the wound swab is defined as the part of the wound protector in contact with the intra-abdominal organs, "outside" is the part in contact with the skin and subcutaneous tissues. Results from inside and outside swabs are then compared to establish whether there is a difference in bacterial flora. The study aims to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric bacteria to the surgical incision site.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominal surgery in which a plastic wound retractor is used

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria.
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively)
timeFrame: 3 years
Other outcomes:
Locations:
city: Dublin 4
country: Ireland
facility: St. Vincent's University Hospital, Elm Park
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital, Eccles Street
Study officials:
affiliation: St Vincent's University Hospital
name: Desmond Winter
role: PRINCIPAL_INVESTIGATOR
References: