An observational study in Bacterial Translocation, Surgical Site Infection and Abdominal Surgery, sponsored by St Vincent's University Hospital, Ireland. Completed at 2 sites in Ireland. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2011-07-20.
Sponsored by St Vincent's University Hospital, Ireland · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 250 is close to the median of 240 across 2,136 observational studies indexed under Infections.
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Patients undergoing abdominal surgery in which a plastic wound retractor is used.
Exclusion Criteria:
Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria.
Time frame: 2 years
Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively)
Time frame: 3 years
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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St Vincent's University Hospital, Ireland