CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Dabir Air overlaydevice
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/NCT03317288
NCT03317288N/ACompleted

Effect of Alternating Pressure Overlay on Weight Bearing Tissue Tolerance in People With Spinal Cord Injury

University of Illinois at Chicago·interventional·Posted Oct 23, 2017·Updated Jun 9, 2021

In Brief

A clinical study evaluating Dabir Air overlay for Spinal Cord Injuries and Pressure Ulcer. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The purpose of this study is to test if the newly-developed Dabir alternating pressure (AP) overlay could be beneficial to preventing skin damage during daily activities, such as lying in bed. Specifically, the study is being done to test if the Dabir AP overlay could be used to increase skin tolerance when lying in bed for an extended period of time (40 minutes), including reducing pressure and increasing skin blood flow (amount of blood supply to oxygen and nutrients to skin) as compared to regular operation room (OR) overlay. A total of 20 participants with spinal cord injury will be recruited. Subjects will undergo study procedures including: AP and Control protocols. Skin blood flow and interface pressure will be collected non-invasively (from outside the body) during both protocols. During AP protocols, subject will be asked to lie on side (10 min), on back on AP overlay (40 min), on side (30 min), on back on OR overlay (40 min), and on side (10 min). During Control protocol, subject will be asked to lie on side (10 min), on back on OR overlay (40 min), and on side (10 min). Subject will then proceed to vascular control measures, including: non-invasive skin blood flow and tissue oxygen measurements with mild heating and electrical stimulation. Findings from this study will help us understand the effectiveness of the AP overlay on skin blood flow response during prolonged lying in bed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDabir Surfaces Inc

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 23, 2017
Enrollment StartMay 12, 2017
Primary CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.7 years ago

Interventions

Dabir Air overlaydevice

The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table.