Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial

Infection Clinical Trial

Official title:

Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780453
• Other study ID #: PICO Trial
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2016
• Last updated: November 26, 2016
• Start date: January 2013
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: University Hospital of Limerick
• Contact: n/a
• Is FDA regulated: No
• Health authority: Research Ethics Committee University Hospital Limerick Ireland':'
• Study type: Interventional

Clinical Trial Summary

Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Elective and emergency abdominal surgery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

Device:
• Negative pressure dressing

• Standard wound dressing

Locations

Country	Name	City	State
Ireland	University Hospital Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection rate		30 days	No