N/A
N=15
Alternating Pressure Overlay on Weight Bearing Tissue Tolerance in People With Spinal Cord Injury
Spinal Cord Injuries · Pressure Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03317288 ↗Enrolled (actual)
15
Serious AEs
—
Results posted
Jun 2021
Primary outcome: Primary: Sacral Skin Blood Flow During Supine Lying — 12.65; 15.54; 11.96 arbitrary unit
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dabir Air overlay (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sacral Skin Blood Flow During Supine Lying |
12.65; 15.54; 11.96 | — |
| PRIMARY Heel Skin Blood Flow During Supine Lying |
15.10; 27.92; 10.43 | — |
| PRIMARY Sacral Peak Interface Pressure During Supine Lying |
89.27; 51.47; 114.13 | — |
| PRIMARY Sacral Averaged Interface Pressure During Supine Lying |
57.21; 36.16; 81.50 | — |
| PRIMARY Heel Peak Interface Pressure During Supine Lying |
52.49; 26.79; 53.05 | — |
| PRIMARY Heel Averaged Interface Pressure During Supine Lying |
37.88; 14.60; 34.83 | — |
| SECONDARY Post Alternating Pressure Sacral Skin Blood Flow |
15.78; 11.96 | — |
| SECONDARY Post Alternating Pressure Sacral Peak Interface Pressure |
104.62; 114.13 | — |
| SECONDARY Post Alternating Pressure Sacral Averaged Interface Pressure |
81.07; 81.50 | — |
| SECONDARY Post Alternating Pressure Heel Skin Blood Flow |
16.31; 10.43 | — |
| SECONDARY Post Alternating Pressure Heel Peak Interface Pressure |
47.69; 53.05 | — |
| SECONDARY Post Alternating Pressure Heel Averaged Interface Pressure |
30.35; 34.83 | — |
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.
Eligibility Criteria
Inclusion Criteria
- have had spinal cord injury for more than one year
- have injury level at T10 or above
- not ambulatory and use a wheelchair for mobility
- none smokers or able to refrain from smoking four hours prior to and during the study
Exclusion Criteria
- current pressure ulcer
- history of diabetes mellitus
- history of cardiovascular diseases
- history of hypertension
- history of pulmonary diseases
- pregnant women (based on a positive pregnancy test)
- Non-English speakers
Data sourced from ClinicalTrials.gov (NCT03317288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.