NCT05090462

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

October 8, 2021

Last Update Submit

October 21, 2021

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • SSI Day 7

    Presence of SSI

    Day 7

Secondary Outcomes (6)

  • SSI Day 7

    Day 28

  • Length of stay

    through study completion, an average of 6 months

  • Surgical site complications

    Day 28

  • Reoperation

    Day 28

  • SSI grading

    Day 28

  • +1 more secondary outcomes

Study Arms (2)

Standard surgical dressings (Clearpore)

NPWT dressing (PICO)

Device: PICO dressing

Interventions

PICO dressingDEVICE

Negative Pressure Wound Therapy device

NPWT dressing (PICO)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All emergency midline laparotomy
  • Laparoscopic converted open

You may not qualify if:

  • \- Reoperation with 28 days of index laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nader University Bedwani

London, N18 1QX, United Kingdom

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Will be shared through IRAS

Shared Documents
STUDY PROTOCOL, SAP

Locations

GB(1)