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Simplified Negative Pressure Wound Therapy

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ClinicalTrials.gov Identifier: NCT01339429
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : May 20, 2015
Last Update Posted : May 20, 2015
Sponsor:
Collaborators:
Center for Integration of Medicine & Innovative Technology
Fogarty International Clinical Research Scholarship
Information provided by (Responsible Party):
Robert Riviello, Brigham and Women's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wounds Device: simplified negative pressure wound therapy device (Wound Pump device) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device
Study Start Date : March 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339429


Locations
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Rwanda
Rwinkwavu Hospital
Rwinkwavu, Kayonza District, Rwanda
Central University Teaching Hospital in Kigali
Kigali, Rwanda
Sponsors and Collaborators
Brigham and Women's Hospital
Center for Integration of Medicine & Innovative Technology
Fogarty International Clinical Research Scholarship
Investigators
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Principal Investigator: Robert Riviello, M.D., M.P.H. Brigham and Women's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert Riviello, Instructor in Surgery, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01339429    
Other Study ID Numbers: 2010-P-002279/1
First Posted: April 20, 2011    Key Record Dates
Results First Posted: May 20, 2015
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Robert Riviello, Brigham and Women's Hospital:
wound
negative pressure wound therapy
non-powered negative pressure wound therapy
Additional relevant MeSH terms:
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Wounds and Injuries