An interventional study of Mapping System and Non-Mapping System in Ulcers and Bedsores, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Prevention
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's enrollment of 428 is above the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Mapping System
Device: Non-Mapping System
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
Standard ICU bed with no mapping system
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
Comparing number of pressure ulcers when using pressure mapping compared to when not.
Time frame: Time admitted in the Medical Intensive Care Unit
| Milestone | Patients on Mapping Systems | Patients Not on Mapping Systems |
|---|---|---|
| Started | 216 | 212 |
| Completed | 216 | 212 |
| Not completed | 0 | 0 |
Comparing number of pressure ulcers when using pressure mapping compared to when not.
| Participants | Patients on Mapping Systems | Patients Not on Mapping Systems |
|---|---|---|
| Pressure Mapping Reducing Hospital Acquired Pressure Ulcers | 2 | 10 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients on Mapping Systems | — | 0/213 (0%) | 0/213 (0%) |
| Patients Not on Mapping Systems | — | 0/209 (0%) | 0/209 (0%) |
| Age, Categorical(Participants) | Patients on Mapping Systems | Patients Not on Mapping Systems | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 143 | 138 | 281 |
| >=65 years | 73 | 74 | 147 |
| Age, Continuous(years) | Patients on Mapping Systems | Patients Not on Mapping Systems | Total |
|---|---|---|---|
| Mean | 58.7 (19 to 96) | 56.9 (18 to 93) | 57.8 (18 to 96) |
| Sex: Female, Male(Participants) | Patients on Mapping Systems | Patients Not on Mapping Systems | Total |
|---|---|---|---|
| Female | 110 | 102 | 212 |
| Male | 106 | 110 | 216 |
| Region of Enrollment(participants) | Patients on Mapping Systems | Patients Not on Mapping Systems | Total |
|---|---|---|---|
| United States | 216 | 212 | 428 |
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Henry Ford Health System