Trial Outcomes & Findings for An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions (NCT NCT00178126)

NCT ID: NCT00178126

Last Updated: 2017-06-02

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

232 participants

Primary outcome timeframe

6 months

Results posted on

2017-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Segmented Foam Cushion Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion	Skin Protection Cushion Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion
Overall Study STARTED	119	113
Overall Study COMPLETED	94	86
Overall Study NOT COMPLETED	25	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Segmented Foam Cushion Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion	Skin Protection Cushion Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion
Overall Study Lost to Follow-up	21	21
Overall Study did not receive intervention	4	6

Baseline Characteristics

An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Segmented Foam Cushion n=119 Participants Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion	Skin Protection Cushion n=113 Participants Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion	Total n=232 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	119 Participants n=99 Participants	113 Participants n=107 Participants	232 Participants n=206 Participants
Age, Continuous	86.5 years STANDARD_DEVIATION 7.7 • n=99 Participants	86.7 years STANDARD_DEVIATION 7.4 • n=107 Participants	86.6 years STANDARD_DEVIATION 7.6 • n=206 Participants
Sex: Female, Male Female	106 Participants n=99 Participants	91 Participants n=107 Participants	197 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	22 Participants n=107 Participants	35 Participants n=206 Participants
Body Mass Index	25.0 kg/m^2 STANDARD_DEVIATION 5.2 • n=99 Participants	24.6 kg/m^2 STANDARD_DEVIATION 4.4 • n=107 Participants	24.8 kg/m^2 STANDARD_DEVIATION 4.8 • n=206 Participants
Incontinence	97 participants n=99 Participants	97 participants n=107 Participants	194 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Segmented Foam Cushion n=119 Participants Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion	Skin Protection Cushion n=113 Participants Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion
Sitting-induced Pressure Ulcers	8 participants	1 participants

Adverse Events

Segmented Foam Cushion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Skin Protection Cushion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Brienza

University of PIttsburgh

Phone: (412) 624-6383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place