Trial Outcomes & Findings for Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended (NCT NCT02224404)

Results Overview

the subjects will be measured by the following variables; maceration,

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Fast Gelling Dressing Fast Gelling Dressing (Exufiber)
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fast Gelling Dressing n=21 Participants Fast Gelling Dressing (Exufiber)
Age, Continuous	69.7 years STANDARD_DEVIATION 19.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants
Region of Enrollment Finland	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

the subjects will be measured by the following variables; maceration,

Outcome measures

Outcome measures
Measure	Fast Gelling Dressing n=21 Participants Fast Gelling Dressing (Exufiber)
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)	2 participants

SECONDARY outcome

Timeframe: 6 weeks

Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm

Outcome measures

Outcome measures
Measure	Fast Gelling Dressing n=21 Participants Fast Gelling Dressing (Exufiber)
Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance	0 units on a scale Interval 0.0 to 50.0

Adverse Events

Fast Gelling Dressing

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fast Gelling Dressing n=21 participants at risk Fast Gelling Dressing (Exufiber)
General disorders Nausea and vomiting	4.8% 1/21 • Number of events 1

Other adverse events

Other adverse events
Measure	Fast Gelling Dressing n=21 participants at risk Fast Gelling Dressing (Exufiber)
Skin and subcutaneous tissue disorders Periwound redness	4.8% 1/21 • Number of events 1

Additional Information

Dr. Hilde Beele

Universitair Ziekenhuis Gent

Phone: 09/332 22 87

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60