Simplified Negative Pressure Wound Therapy

Phase 1

Completed

Interventions: Device: simplified negative pressure wound therapy device (Wound Pump device)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
simplified Negative Pressure Wound Therapy	simplified negative pressure wound therapy device (Wound Pump device)	The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria.

Primary Outcome Measures

Name	Time	Method
Maintenance of Negative Pressure	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

Name	Time	Method
Number of Participants With Serious Adverse Events	3 days	Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.