Plastic Wound Retractors and Bacterial Translocation in Abdominal Surgery

Surgical Site Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007487
• Other study ID #: HMSVUH1
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: July 19, 2011
• Start date: January 2008
• Est. completion date: July 2010

Study information

• Verified date: November 2009
• Source: St Vincent's University Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Surgery
• Bacterial Translocation
• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection
• Wound Infection

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital, Eccles Street	Dublin
Ireland	St. Vincent's University Hospital, Elm Park	Dublin 4

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's University Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria.		2 years	No
Secondary	Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively)		3 years	No