Simplified Negative Pressure Wound Therapy
Primary Purpose
Wounds
Status
Completed
Phase
Phase 1
Locations
Rwanda
Study Type
Interventional
Intervention
simplified negative pressure wound therapy device (Wound Pump device)
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring wound, negative pressure wound therapy, non-powered negative pressure wound therapy
Eligibility 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
Sites / Locations
- Rwinkwavu Hospital
- Central University Teaching Hospital in Kigali
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
simplified Negative Pressure Wound Therapy
Arm Description
The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria.
Outcomes
Primary Outcome Measures
Maintenance of Negative Pressure
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
Number of Participants With Serious Adverse Events
Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.
Full Information
NCT ID
NCT01339429
First Posted
March 28, 2011
Last Updated
May 19, 2015
Sponsor
Brigham and Women's Hospital
Collaborators
Center for Integration of Medicine & Innovative Technology, Fogarty International Clinical Research Scholarship
1. Study Identification
Unique Protocol Identification Number
NCT01339429
Brief Title
Simplified Negative Pressure Wound Therapy
Official Title
Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Center for Integration of Medicine & Innovative Technology, Fogarty International Clinical Research Scholarship
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
wound, negative pressure wound therapy, non-powered negative pressure wound therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
simplified Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria.
Intervention Type
Device
Intervention Name(s)
simplified negative pressure wound therapy device (Wound Pump device)
Other Intervention Name(s)
Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.
Intervention Description
A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.
Primary Outcome Measure Information:
Title
Maintenance of Negative Pressure
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events
Description
Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riviello, M.D., M.P.H.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rwinkwavu Hospital
City
Rwinkwavu
State/Province
Kayonza District
Country
Rwanda
Facility Name
Central University Teaching Hospital in Kigali
City
Kigali
Country
Rwanda
12. IPD Sharing Statement
Citations:
PubMed Identifier
25502858
Citation
Mody GN, Zurovcik DR, Joharifard S, Kansayisa G, Uwimana G, Baganizi E, Ntakiyiruta G, Mugenzi D, Riviello R. Biomechanical and safety testing of a simplified negative-pressure wound therapy device. Plast Reconstr Surg. 2015 Apr;135(4):1140-1146. doi: 10.1097/PRS.0000000000001101. Erratum In: Plast Reconstr Surg. 2015 Jun;135(6):1756.
Results Reference
derived
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Simplified Negative Pressure Wound Therapy
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