Trial Outcomes & Findings for Post Market Clinical Follow-up Study (NCT NCT01841567)

NCT ID: NCT01841567

Last Updated: 2014-09-30

Results Overview

Number of participants without blisters at study visit

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2014-09-30

Participant Flow

Participant milestones

Measure	Dressing Mepilex border post. op Mepilex border post op
Overall Study STARTED	60
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Dressing Mepilex border post. op Mepilex border post op
Overall Study Adverse Event	3

Baseline Characteristics

Post Market Clinical Follow-up Study

Baseline characteristics by cohort

Measure	Dressing n=60 Participants Mepilex border post. op Mepilex border post op
Age, Continuous	65.2 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment Germany	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Number of participants without blisters at study visit

Outcome measures

Measure	Dressing n=60 Participants Mepilex border post. op Mepilex border post op
Minimize the Risk of the Development of Blistering.	60 participants

SECONDARY outcome

Timeframe: 7 days

The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery

Outcome measures

Measure	Dressing n=60 Participants Mepilex border post. op Mepilex border post op
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.	60 participants

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

Adverse Events

Dressing

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dressing n=60 participants at risk Mepilex border post. op Mepilex border post op
Cardiac disorders •Cardiac disorders	1.7% 1/60 • Number of events 1
Surgical and medical procedures surgical and medical procedures	1.7% 1/60 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr Kourosh Zarghooni

Klinik und Poliklinik für Orthopädie und Unfallchirurgie der Uniklinik Köln

Phone: +49 2247887294

Email: kourosh.zarghooni@uk-koeln.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER