Simplified Negative Pressure Wound Therapy

Brigham and Women's Hospital41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wounds

Interventions

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.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Rwinkwavu Hospital

Rwinkwavu, Kayonza District, Rwanda

Central University Teaching Hospital in Kigali

Kigali, Kigali, Rwanda

Outcomes

Primary Outcomes

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.

Time frame: 3 days

Secondary Outcomes

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.

Time frame: 3 days

Data from ClinicalTrials.gov

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