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CompletedNCT02739191NEWTONUpdated Jan 19, 2018

Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle

An interventional study of PICO, Smith & Nephew in Negative Pressure Wound Therapy, Vacuum Therapy and Closed Incisions, sponsored by J.C. Goslings. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by J.C. Goslings · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Negative Pressure Wound Therapy
  • Vacuum Therapy
  • Closed Incisions

Keywords

  • NPWT
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 60 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

This is the only study on the registry with J.C. Goslings as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Intervention

    Prophylactic negative pressure wound therapy

    Device: PICO, Smith & Nephew

Interventions

  • DevicePICO, Smith & Nephew

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

06

What researchers measure

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.

    Time frame: 30 days

Secondary outcomes

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

    To asses functional outcome of the participants the AOFAS questionnaire will be used

    Time frame: 6 months

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

    To asses the quality of life of the participants the EQ-5D questionnaire will be used

    Time frame: 6 months

07

Study locations

1 site
  • Academic Medical Center
    Amsterdam, Noord-Holland 1105AZ, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02739191
Lead sponsor
J.C. Goslings
Responsible party
J.C. Goslings (Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Sponsor-investigator
First posted
Apr 15, 2016
Start date
Apr 2016
Primary completion
Mar 2017
Completion
Aug 2017
Last update
Jan 19, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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