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Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial

NCT ID: NCT02780453

Last Updated: 2016-11-29

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-10-31

Brief Summary

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Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.

Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Negative pressure dressing

Negative pressure dressing

Group Type EXPERIMENTAL

Negative pressure dressing

Intervention Type DEVICE

Standard dressing

Standard wound dressing

Group Type ACTIVE_COMPARATOR

Standard wound dressing

Intervention Type DEVICE

Interventions

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Negative pressure dressing

Intervention Type DEVICE

Standard wound dressing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elective and emergency abdominal surgery

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital of Limerick

OTHER

Sponsor Role lead

Responsible Party

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Peter O'Leary

Surgery SPR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Limerick

Limerick, Limerick, Ireland

Site Status

Countries

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Ireland

References

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O'Leary DP, Peirce C, Anglim B, Burton M, Concannon E, Carter M, Hickey K, Coffey JC. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations: A Randomized, Controlled, Open-label Trial: The P.I.C.O. Trial. Ann Surg. 2017 Jun;265(6):1082-1086. doi: 10.1097/SLA.0000000000002098.

Reference Type DERIVED
PMID: 27926575 (View on PubMed)

Other Identifiers

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PICO Trial

Identifier Type: -

Identifier Source: org_study_id