Simplified Negative Pressure Wound Therapy

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Wounds

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01339429

2010-P-002279/1

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 14 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

simplified Negative Pressure Wound Therapy

Experimental group

Description:

The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria.

Treatment:

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