NCT03317288

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

Completed NA Results posted Last updated 9 June 2021

What this trial tests

NA trial testing Dabir Air overlay in Spinal Cord Injuries in 15 participants. Completed in 31 March 2019.

Timeline

12 May 2017

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	15
Start date	12 May 2017
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Dabir Air overlay

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Pressure Ulcer — all drugs for Pressure Ulcer →

Sponsor

University of Illinois at Chicago

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injuries or Pressure Ulcer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sacral Skin Blood Flow During Supine Lying Primary · 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Sacral skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad with and without alternating pressure overlay

Group	Value	95% CI
Alternating Pressure -- Inflation Cycle	12.65	± 12.45
Alternating Pressure -- Deflation Cycle	15.54	± 15.33
Control (Operating Room Pad Only)	11.96	± 10.26

Heel Skin Blood Flow During Supine Lying Primary · 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Heel skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad with and without alternating pressure overlay

Group	Value	95% CI
Alternating Pressure -- Inflation Cycle	15.10	± 20.78
Alternating Pressure -- Deflation Cycle	27.92	± 32.15
Control (Operating Room Pad Only)	10.43	± 11.16

Sacral Peak Interface Pressure During Supine Lying Primary · 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Sacral peak interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the maximum interface pressure of the nine pressure cells located at the sacrum.

Group	Value	95% CI
Alternating Pressure -- Inflation Cycle	89.27	± 53.92
Alternating Pressure -- Deflation Cycle	51.47	± 30.18
Control (Operating Room Pad Only)	114.13	± 60.97

Sacral Averaged Interface Pressure During Supine Lying Primary · 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Sacral averaged interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the averaged interface pressure of the nine pressure cells located at the sacrum.

Group	Value	95% CI
Alternating Pressure -- Inflation Cycle	57.21	± 28.54
Alternating Pressure -- Deflation Cycle	36.16	± 18.47
Control (Operating Room Pad Only)	81.50	± 46.39

Heel Peak Interface Pressure During Supine Lying Primary · 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Heel peak interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the maximum interface pressure of the nine pressure cells located at the heel.

Group	Value	95% CI
Alternating Pressure -- Inflation Cycle	52.49	± 21.21
Alternating Pressure -- Deflation Cycle	26.79	± 12.91
Control (Operating Room Pad Only)	53.05	± 18.22

Heel Averaged Interface Pressure During Supine Lying Primary · 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Heel averaged interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the averaged interface pressure of the nine pressure cells located at the heel.

Group	Value	95% CI
Alternating Pressure -- Inflation Cycle	37.88	± 17.27
Alternating Pressure -- Deflation Cycle	14.60	± 8.37
Control (Operating Room Pad Only)	34.83	± 16.62

Post Alternating Pressure Sacral Skin Blood Flow Secondary · 40 minutes

Sacral skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Group	Value	95% CI
Post Alternating Pressure	15.78	± 15.82
Control	11.96	± 10.26

Post Alternating Pressure Sacral Peak Interface Pressure Secondary · 40 minutes

Sacral peak interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Group	Value	95% CI
Post Alternating Pressure	104.62	± 58.17
Control	114.13	± 60.97

Post Alternating Pressure Sacral Averaged Interface Pressure Secondary · 40 minutes

Sacral averaged interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Group	Value	95% CI
Post Alternating Pressure	81.07	± 48.62
Control	81.50	± 46.39

Post Alternating Pressure Heel Skin Blood Flow Secondary · 40 minutes

Heel skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Group	Value	95% CI
Post Alternating Pressure	16.31	± 29.18
Control	10.43	± 11.16

Post Alternating Pressure Heel Peak Interface Pressure Secondary · 40 minutes

Heel peak interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Group	Value	95% CI
Post Alternating Pressure	47.69	± 16.21
Control	53.05	± 18.22

Post Alternating Pressure Heel Averaged Interface Pressure Secondary · 40 minutes

Heel averaged interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Group	Value	95% CI
Post Alternating Pressure	30.35	± 17.59
Control	34.83	± 16.62

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reactive Oxygen Species and Pressure Ulcer Formation after Traumatic Injury to Spinal Cord and Brain.
   Kumar S, Theis T, Tschang M, Nagaraj V, et al · · 2021 · cited 26× · PMID 34202655 · DOI 10.3390/antiox10071013