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NCT05090462 Clinical Trial

PICO Dressings for Emergency Laparotomy

Surgical Site Infection Clinical Trial

Official title:
The Use of PICO Dressings for Patients Undergoing Emergency Laparotomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05090462
Other study ID # 1234
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date June 1, 2022

Study information
Verified date October 2021
Source North Middlesex University Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

SSI (Surgical Site Infection) rate is an important consideration after emergency laparotomy. SSIs carry a high financial burden for health institutes with the cost of major SSIs after emergency laparotomy to add an additional cost of £10000-£15000 per patient. NICE has recommended the use of PICO dressings for the reduction of SSI rate as a cost-neutral. The purpose of this study was to review the current SSI rate, assess the patient risk factors for development of SSIs and evaluate if the use of PICO dressings as per NICE guidelines will reduce the SSI rate.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All emergency midline laparotomy - Laparoscopic converted open Exclusion Criteria: - Reoperation with 28 days of index laparotomy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PICO dressing
Negative Pressure Wound Therapy device

Locations
Country Name City State
United Kingdom Nader University Bedwani London

Sponsors (1)
Lead Sponsor Collaborator
North Middlesex University Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary SSI Day 7 Presence of SSI Day 7
Secondary SSI Day 7 Presence of SSI Day 28
Secondary Length of stay Length of stay through study completion, an average of 6 months
Secondary Surgical site complications Number of participants with other complications of the wound to include dehiscence and burst abdomen Day 28
Secondary Reoperation Number of participants undergoing reoperation Day 28
Secondary SSI grading SSI grading as per Southampton scoring system (if applicable) (Grade 0-5 with 5 being worse outcome) Day 28
Secondary Length of antibiotic therapy Duration of post-operative antibiotic therapy Day 28
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