Simplified Negative Pressure Wound Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Wounds

Intervention / Treatment
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* Device: simplified negative pressure wound therapy device (Wound Pump device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simplified Negative Pressure Wound Therapy<br>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)<br>* A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.<br>* Other names: Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound, negative pressure wound therapy, non-powered negative pressure wound therapy