Plastic Wound Retractors and Bacterial Translocation in Abdominal Surgery

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.

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Surgery; Surgical Site Infection; Wound Infection; Bacterial Translocation

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, Dublin 1
    • Mater Misericordiae University Hospital, Eccles Street
  • Dublin 4, Ireland
    • St. Vincent's University Hospital, Elm Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively)	3 years

Collaborators and Investigators

• Sponsor: St Vincent's University Hospital, Ireland
• Investigators: Principal Investigator: Desmond Winter, St Vincent's University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (ESTIMATE): November 4, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Wound infection; Surgical site infection; Abdominal surgery; Bacterial translocation; Plastic wound protector; Plastic wound retractor
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: HMSVUH1