NCT02780453

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

May 19, 2016

Last Update Submit

November 26, 2016

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection rate

    30 days

Study Arms (2)

Negative pressure dressing

EXPERIMENTAL

Negative pressure dressing

Device: Negative pressure dressing

Standard dressing

ACTIVE COMPARATOR

Standard wound dressing

Device: Standard wound dressing

Interventions

Negative pressure dressingDEVICE
Negative pressure dressing
Standard wound dressingDEVICE
Standard dressing

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective and emergency abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Limerick

Limerick, Limerick, -00-, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 27926575DERIVED

MeSH Terms

Conditions

Infections

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgery SPR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 23, 2016

Study Start

January 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

IE(1)