PICO Dressings for Emergency Laparotomy

NCT ID: NCT05090462

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Site Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard surgical dressings (Clearpore)

No interventions assigned to this group

NPWT dressing (PICO)

PICO dressing

Intervention Type DEVICE

Negative Pressure Wound Therapy device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PICO dressing

Negative Pressure Wound Therapy device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All emergency midline laparotomy
* Laparoscopic converted open

Exclusion Criteria

\- Reoperation with 28 days of index laparotomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North Middlesex University Hospital NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nader Bedwani

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nader University Bedwani

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nader U Bedwani, MRCS

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1234

Identifier Type: -

Identifier Source: org_study_id