NCT03871023

Brief Summary

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature. The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.

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
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

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

March 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

March 7, 2019

Last Update Submit

September 17, 2019

Conditions

Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay

Outcome Measures

Primary Outcomes (2)

  • superficial site infection via southampton scoring system (higher score - worse outcome)

    seroma/haematoma/abscess formation

    5 days

  • Wound Dehisence

    disruption of wound continuity

    5 days

Secondary Outcomes (3)

  • Wound healing/Cosmesis

    week 6 post op

  • Length of hospital stay

    30 days

  • home care therapy

    30days

Study Arms (3)

Simple dressing

ACTIVE COMPARATOR

Standard, waterproof dressing applied to wound

Device: Smith & Nephew PICO Negative wound pressure versus standard dresingDevice: PREVENA Negative pressure wound versus standard dressing

PICO Dressing

ACTIVE COMPARATOR

Negative Wound pressure applied second cohort

Device: PREVENA Negative pressure wound versus standard dressing

PREVENA Dressing

ACTIVE COMPARATOR

Negative wound presure applied to third cohort

Device: Smith & Nephew PICO Negative wound pressure versus standard dresing

Interventions

Smith & Nephew PICO Negative wound pressure versus standard dresingDEVICE

To investigate if negative wound pressure improves wound outcome

PREVENA DressingSimple dressing
PREVENA Negative pressure wound versus standard dressingDEVICE

To investigate if negative wound pressure improves wound outcome

PICO DressingSimple dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnant patients and those undergoing re-look laparotomies are to be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. James' Hospital

Dublin, D8, Ireland

Location

Related Publications (1)

  • Donlon NE, Boland PA, Kelly ME, Schmidt K, Cooke F, Neary PM, Barry KM, Reynolds JV. Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial. Int J Colorectal Dis. 2019 Nov;34(11):2003-2010. doi: 10.1007/s00384-019-03398-9. Epub 2019 Sep 16.

    PMID: 31529194DERIVED

MeSH Terms

Conditions

Wound InfectionWounds and Injuries

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Noel E Donlon

    St. James's Hospital, Ireland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noel E Donlon

CONTACT

00353863557726donlonn@tcd.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 3 separate treatment arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Registrar General Surgery

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 12, 2019

Study Start

November 6, 2019

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Deleted post analysis

Locations

IE(1)