Plastic Wound Retractors and Bacterial Translocation in Abdominal Surgery

NCT01007487 | Completed

• 1 other identifier: HMSVUH1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria.

  2 years

Secondary Outcomes (1)

• Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively)

  3 years

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

Study Sites (2)

Mater Misericordiae University Hospital, Eccles Street

Dublin, Dublin 1, Ireland

Location

St. Vincent's University Hospital, Elm Park

Dublin, Ireland

Location

MeSH Terms

Conditions

Surgical Wound Infection; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Desmond Winter

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: January 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 20, 2011

Record last verified: 2009-11

Locations

IE (2)