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

NCT03317288 | Completed Results FDA Device

• 1 other identifier: 2017-0215
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Pressure Ulcer

Keywords

spinal cord injury; pressure ulcer; laser Doppler flowmetry

Outcome Measures

Primary Outcomes (6)

• Sacral Skin Blood Flow During Supine Lying

  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

  40 minutes, the inflation-deflation cycle alternates every 10 minutes

• Heel Skin Blood Flow During Supine Lying

  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

  40 minutes, the inflation-deflation cycle alternates every 10 minutes

• Sacral Peak Interface Pressure During Supine Lying

  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.

  40 minutes, the inflation-deflation cycle alternates every 10 minutes

• Sacral Averaged Interface Pressure During Supine Lying

  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.

  40 minutes, the inflation-deflation cycle alternates every 10 minutes

• Heel Peak Interface Pressure During Supine Lying

  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.

  40 minutes, the inflation-deflation cycle alternates every 10 minutes

• Heel Averaged Interface Pressure During Supine Lying

  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.

  40 minutes, the inflation-deflation cycle alternates every 10 minutes

Secondary Outcomes (6)

• Post Alternating Pressure Sacral Skin Blood Flow

  40 minutes

• Post Alternating Pressure Sacral Peak Interface Pressure

  40 minutes

• Post Alternating Pressure Sacral Averaged Interface Pressure

  40 minutes

• Post Alternating Pressure Heel Skin Blood Flow

  40 minutes

• Post Alternating Pressure Heel Peak Interface Pressure

  40 minutes

Study Arms (1)

SCI subjects

OTHER

The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay.

Device: Dabir Air overlay

Interventions

Dabir Air overlay DEVICE

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

SCI subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Dabir Surfaces Inc: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Small sample size with very strict criteria, results could not be generalized to other population.

Results Point of Contact

• Title: Dr. Yi-Ting Tzen
• Organization: UT Southwestern Medical Center

Yi-Ting.Tzen@UTSouthwestern.edu

2146481786

Study Officials

• Yi-Ting Tzen, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Here is no masking of the intervention.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Repeated measures design. Subject serves as his or her own control.

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 23, 2017
• Study Start: May 12, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-05

Locations

US (1)