Skip to main content
OpenTrials
Completed

NCT Number: NCT01339429

Simplified Negative Pressure Wound Therapy

The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wounds Wounds and Injuries

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rwinkwavu Hospital, Rwinkwavu, Kayonza District, Rwanda

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • open wound appropriate for NPWT
  • wound size greater than 2 cm2 and less than 150 cm2
  • adequate adjacent intact skin for application of sNPWT
  • adequate contour of wound location for application of sNPWT
  • patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
  • the patient is expected to remain clinically stable for the duration of the study
  • the patient is to remain hospitalized for the duration of the study
  • patient or their legal representative is willing and able to sign an IRB-approved informed consent
  • patient less than 21 years old is willing to sign an approved assent form if able to sign

Exclusion criteria

  • exposed blood vessels
  • ischemic wound
  • wound with necrotic tissue requiring further debridement at the time of enrollment
  • infection
  • acute osteomyelitis
  • malignancy in the wound
  • latex or rubber containing product sensitivity

Treatment and study plan

simplified negative pressure wound therapy device (Wound Pump device)

Device

A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.

Other names: Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.

Primary outcomes

  1. Maintenance of Negative Pressure

    Time frame: 3 days

    The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.

Secondary outcomes

  1. Number of Participants With Serious Adverse Events

    Time frame: 3 days

    Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Center for Integration of Medicine & Innovative Technology
  • Fogarty International Clinical Research Scholarship

Registry information

Official study title

Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2011
Registry last updated
May 20, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.