NCT02739191

Brief Summary

Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

April 9, 2016

Last Update Submit

January 17, 2018

Conditions

Negative Pressure Wound TherapyVacuum TherapyClosed Incisions

Keywords

NPWT

Outcome Measures

Primary Outcomes (1)

  • Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria.

    The number of POWI's within 30 days of surgery will be recorded. These will be classified in superficial and deep POWI's using the criteria as proposed by the CDC.

    30 days

Secondary Outcomes (2)

  • The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months

    6 months

  • EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months

    6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Prophylactic negative pressure wound therapy

Device: PICO, Smith & Nephew

Interventions

PICO, Smith & NephewDEVICE

Direct application of negative pressure wound therapy following Foot and Ankle surgery

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 and ≤ 80 years
  • Orthopedic (trauma) surgery to the foot and/or ankle
  • Incision \>3 cm

You may not qualify if:

  • Open fractures
  • Antibiotic treatment at the time of the operation for a concomitant disease or infection
  • Insufficient comprehension of the Dutch language
  • Patients with immune-deficiencies
  • Inability to address negative pressure wound therapy device
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2016

First Posted

April 15, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

August 1, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

NL(1)