PICO Dressings for Emergency Laparotomy | NCT05090462

Studies
PICO Dressings for Emergency Laparotomy

NCT05090462

Sponsor

North Middlesex University Hospital NHS Trust

Status

Unknown status

Last Update Posted

Oct 22, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Surgical Site Infection

Interventions

PICO dressing

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Estimated

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Oct 8, 2021

First Submission Date that Met QC Criteria

Oct 21, 2021

First Posted Date

Oct 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2021

Last Update Posted Date

Oct 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nader Bedwani, Principal Investigator, North Middlesex University Hospital NHS TrustPrincipal Investigator

Lead Sponsor

North Middlesex University Hospital NHS TrustOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard surgical dressings (Clearpore)
NPWT dressing (PICO)			Device: PICO dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PICO dressing	Device	Negative Pressure Wound Therapy device	NPWT dressing (PICO)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
SSI Day 7	Presence of SSI	Day 28
Length of stay	Length of stay	through study completion, an average of 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All emergency midline laparotomy
Laparoscopic converted open

Exclusion Criteria:

- Reoperation with 28 days of index laparotomy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nader University Bedwani		London		N18 1QX	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Will be shared through IRAS

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided