PICO Dressings for Emergency Laparotomy

October 21, 2021 updated by: Nader Bedwani, North Middlesex University Hospital NHS Trust

The Use of PICO Dressings for Patients Undergoing Emergency Laparotomy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients (>/= 18 years) undergoing emergency (laparotomy) surgery at a single centre (North Middlesex University Hospital, London, UK) will be included.

Description

Inclusion Criteria:

  • All emergency midline laparotomy
  • Laparoscopic converted open

Exclusion Criteria:

- Reoperation with 28 days of index laparotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard surgical dressings (Clearpore)
NPWT dressing (PICO)
Device: PICO dressing
Negative Pressure Wound Therapy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSI Day 7
Time Frame: Day 7
Presence of SSI
Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Middlesex University Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234 (Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be shared through IRAS

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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