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OpenTrials
Completed

NCT Number: NCT02739191

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

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

Completed

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Key information

Conditions

Negative Pressure Wound Therapy Closed Incisions Vacuum Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

PICO, Smith & Nephew

Device

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

Primary outcomes

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

    Time frame: 30 days

    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.

Secondary outcomes

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

J.C. Goslings

Other

Registry information

Acronym: NEWTON

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2016
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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