Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Plastic Wound Retractors and Bacterial Translocation in Abdominal Surgery

This study has been completed.
Sponsor:
Information provided by:
St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01007487
First received: November 3, 2009
Last updated: July 19, 2011
Last verified: November 2009
  Purpose

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.


Condition
Bacterial Translocation
Surgical Site Infection
Abdominal Surgery
Wound Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
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.

Further study details as provided by St Vincent's University Hospital, Ireland:

Primary Outcome Measures:
  • Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007487

Locations
Ireland
Mater Misericordiae University Hospital, Eccles Street
Dublin, Ireland, Dublin 1
St. Vincent's University Hospital, Elm Park
Dublin 4, Ireland
Sponsors and Collaborators
St Vincent's University Hospital, Ireland
Investigators
Principal Investigator: Desmond Winter St Vincent's University Hospital
  More Information

No publications provided

Responsible Party: Desmond Winter, St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier: NCT01007487     History of Changes
Other Study ID Numbers: HMSVUH1
Study First Received: November 3, 2009
Last Updated: July 19, 2011
Health Authority: Ireland: Research Ethics Committee

Keywords provided by St Vincent's University Hospital, Ireland:
Plastic wound protector
Plastic wound retractor
Bacterial translocation
Surgical site infection
Abdominal surgery
Wound infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Wound Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014