NCT02892435

Brief Summary

Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

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

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

May 19, 2015

Last Update Submit

September 1, 2016

Conditions

Wound HealingPrevenaDirty Abdominal SurgeryContaminated Abdominal SurgeryEmergency Abdominal SurgeryNegative-Pressure Wound Therapy

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Infection (SSI) reduction

    quantify SSI decrease after incisional negative pressure wound therapy

    7 months

Secondary Outcomes (1)

  • Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer

    2 years

Study Arms (2)

Prevena arm

EXPERIMENTAL

patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days

Device: incisional negative pressure wound therapy

Control arm

ACTIVE COMPARATOR

patients underwent to contaminated/dirty surgery who positioned conventional dressing

Device: conventional dressing

Interventions

incisional negative pressure wound therapyDEVICE

positioning incisional negative pressure therapy over closed wound.

Also known as: Prevena - KCI
Prevena arm
conventional dressingDEVICE

positioning conventional dressing

Control arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • abdominal surgery
  • open surgery
  • contaminated or dirty surgery

You may not qualify if:

  • not abdominal surgery
  • mininvasive surgery
  • clean surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misericordia e Dolce Hospital

Prato, Po, 59100, Italy

RECRUITING

Study Officials

  • Francesco Feroci, MD

    Ospedale Santo Stefano Prato

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessia Garzi, MD

CONTACT

0574804612alessia.garzi@gmail.com

Marco Scatizzi, MD

CONTACT

0574804612fferoci@usl4.toscana.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, general surgery department

Study Record Dates

First Submitted

May 19, 2015

First Posted

September 8, 2016

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

September 8, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)