Trial Outcomes & Findings for Polyurethane Foam on the Sacrum for Prevention (NCT NCT02692482)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

359 participants

Primary outcome timeframe

On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Results posted on

2019-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Polyurethane Foam Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care	Standard Care standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
Overall Study STARTED	177	182
Overall Study COMPLETED	174	178
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Polyurethane Foam Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care	Standard Care standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
Overall Study Death	2	2
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Polyurethane Foam on the Sacrum for Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polyurethane Foam n=177 Participants Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care	Standard Care n=182 Participants standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.	Total n=359 Participants Total of all reporting groups
Age, Continuous	84.3 years STANDARD_DEVIATION 7.7 • n=5 Participants	83.2 years STANDARD_DEVIATION 7.7 • n=7 Participants	83.7 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	144 Participants n=5 Participants	145 Participants n=7 Participants	289 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Number of Participants with Neck Fracture	94 Participants n=5 Participants	94 Participants n=7 Participants	188 Participants n=5 Participants
Braden score	15.4 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants	15.4 units on a scale STANDARD_DEVIATION 2.0 • n=7 Participants	15.4 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants

PRIMARY outcome

Timeframe: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Outcome measures

Outcome measures
Measure	Polyurethane Foam n=177 Participants Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care	Standard Care n=182 Participants standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
Number of Participants With Pressure Sores	8 Participants	28 Participants

SECONDARY outcome

Timeframe: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Outcome measures

Outcome measures
Measure	Polyurethane Foam n=177 Participants Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care	Standard Care n=182 Participants standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)	7 Participants	7 Participants

SECONDARY outcome

Timeframe: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).

Outcome measures

Outcome measures
Measure	Polyurethane Foam n=177 Participants Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care	Standard Care n=182 Participants standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification	6 Participants	17 Participants

SECONDARY outcome

Timeframe: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Clinical evaluation. It refers to any sort of inflammation and/or discoloration that distorts the skin's normal appearance. The skin may become scaly, bumpy, itchy, or otherwise irritated.

Outcome measures

Outcome measures
Measure	Polyurethane Foam n=177 Participants Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care	Standard Care n=182 Participants standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing	2 Participants	0 Participants

Adverse Events

Polyurethane Foam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cristiana Forni

Istituto Ortopedico Rizzoli

Phone: 0516366694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place