Simplified Negative Pressure Wound Therapy

May 19, 2015 updated by: Robert Riviello, Brigham and Women's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda
        • Central University Teaching Hospital in Kigali
    • Kayonza District
      • Rwinkwavu, Kayonza District, Rwanda
        • Rwinkwavu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: simplified Negative Pressure Wound Therapy
The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria.
Device: simplified negative pressure wound therapy device (Wound Pump 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

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

Investigators

  • Principal Investigator: Robert Riviello, M.D., M.P.H., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-P-002279/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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