CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 41 enrolled
Drug / intervention
simplified negative pressure wound therapy device (Wound Pump device)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01339429
NCT01339429Phase 1Completed
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Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device

Brigham and Women's Hospital·interventional·Posted Apr 20, 2011·Updated May 20, 2015

In Brief

A Phase 1 clinical trial evaluating simplified negative pressure wound therapy device (Wound Pump device) for Wounds. Completed, enrolled 41 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWounds
CountriesRwanda
CollaboratorsCenter for Integration of Medicine & Innovative Technology, Fogarty International Clinical Research Scholarship

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2011
Enrollment StartMar 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.2 years ago

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.