NCT01339429

Simplified Negative Pressure Wound Therapy

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wounds

Interventions

Type	Name	Description
DEVICE	simplified negative pressure wound therapy device (Wound Pump device)	A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-04-20
• Last updated: 2015-05-20
• Results posted: 2015-05-20

Locations

2 sites across 1 country: Rwanda