Simplified Negative Pressure Wound Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Brigham and Women's Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Brigham and Women's Hospital
Collaborators:
Center for Integration of Medicine and Innovative Technology
Fogarty International Clinical Research Scholarship
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01339429
First received: March 28, 2011
Last updated: May 24, 2011
Last verified: May 2011
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Purpose
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 equivalent to the standard NPWT device and that wounds will heal while being treated with sNPWT. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the effects on wound healing of the sNPWT device.
| Condition | Intervention | Phase |
|---|---|---|
|
Wounds |
Device: Wound Pump |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device |
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- maintenance of negative pressure [ Time Frame: 3 days ] [ Designated as safety issue: No ]The negative pressure being delivered by the device will be measured on a daily basis for three days.
Secondary Outcome Measures:
- adverse events [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: simplified Negative Pressure
The simplified Negative Pressure device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria.
|
Device: Wound Pump
A non-powered negative pressure device utilizing a bellows which is compressed every eight hours.
|
Eligibility| Ages Eligible for Study: | 14 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339429
Contacts
| Contact: Gita N Mody, M.D> | 617-921-8221 | gmody@partners.org |
Locations
| Rwanda | |
| Rwinkwavu Hospital | Recruiting |
| Rwinkwavu, Kayonza District, Rwanda | |
| Contact: Gita N. Mody, M.D. 617-921-8221 gmody@partners.org | |
| Sub-Investigator: Gita N. Mody, M.D. | |
| Central University Teaching Hospital in Kigali | Recruiting |
| Kigali, Rwanda | |
| Contact: Gita N. Mody, M.D. 617-921-8221 gmody@partners.org | |
| Sub-Investigator: Gita N. Mody, M.D. | |
Sponsors and Collaborators
Brigham and Women's Hospital
Center for Integration of Medicine and Innovative Technology
Fogarty International Clinical Research Scholarship
Investigators
| Principal Investigator: | Robert Riviello, M.D., M.P.H. | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Robert Riviello/M.D., M.P.H., Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01339429 History of Changes |
| Other Study ID Numbers: | 2010-P-002279/1 |
| Study First Received: | March 28, 2011 |
| Last Updated: | May 24, 2011 |
| Health Authority: | United States: Partners Human Research Committee Institutional Review Board Rwanda: Rwandan National Ethics Committee and Central University Teaching Hospital in Kigali Institutional Review Board United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
wound negative pressure wound therapy non-powered negative pressure wound therapy |
ClinicalTrials.gov processed this record on May 23, 2013