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| Name | Class |
|---|---|
| Center for Integration of Medicine & Innovative Technology | OTHER |
| Fogarty International Clinical Research Scholarship | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simplified Negative Pressure Wound Therapy | Experimental | The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Riviello, M.D., M.P.H. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rwinkwavu Hospital | Rwinkwavu | Kayonza District | Rwanda | |||
| Central University Teaching Hospital in Kigali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25502858 | Derived | 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. |
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47 patients consented. 6 did not meet inclusion criteria. 1 voluntarily withdrew. 4 not enrolled due to clinical changes.
Hospital wards were surveyed daily over the study period for eligible patients. Photographs of wounds ranging from 2-150 cm2 in size and clinical histories were reviewed for study enrollment eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simplified Negative Pressure Wound Therapy | The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound. Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Simplified Negative Pressure Wound Therapy | The simplified Negative Pressure device will be placed on subjects selected from the hospital wards and meeting the eligibility criteria. simplified Negative Pressure device: A non-powered negative pressure device utilizing a bellows which is compressed every eight hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 85 dressings were applied. 5 applications excluded due to a change in patient condition, unrelated to sNPWT. 9 dressings excluded due to occlusion of the drainage tube. 71 dressings were analyzed in total. | Posted | Mean | Standard Deviation | hours | 3 days | dressings | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simplified Negative Pressure Wound Therapy | The simplified negative pressure wound therapy device was placed on subjects selected from the hospital wards and meeting the eligibility criteria regarding wound size and condition. Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Immune system disorders | Systematic Assessment | Fever in an immunocompromised patient after discontinuation of the sNPWT device. Deemed not to be serious nor unexpected by IRB. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gita Mody | Brigham and Women's Hospital | 617-921-8221 | gmody@partners.org |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Kigali |
| Kigali |
| Rwanda |
| participants |
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| Sex/Gender, Customized | Gender was not consistently recorded. | Number | participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Number | participants | 3 days | dressings | Participants |
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| 0 |
| 41 |
| 1 |
| 41 |
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