Completed

NCT Number: NCT01841567

Post Market Clinical Follow-up Study

The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).

Completed

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Key information

Conditions

Hip or Knee Surgery

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

universitätsklinikum Köln

Cologne, Köln, 50924, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 45 years
Have an expected total length of stay of 4 or more days
Undergoing elective primary arthroplasty of the hip or knee
Undergoing hip surgery with a standard access
Give their written informed consent to participate

Exclusion criteria

Dressing size does not fit the incision area
Known allergy hypersensitivity to any of the components of the dressing
Multi-trauma
Undergoing arthroplasty due to tumour
Fractures
Wound at the surgical site prior to surgery
Neurological deficit of operated side
Subject has documented skin disease at time of enrolment, as judged by the investigator
Previously enrolled in the present investigation
Subject included in other ongoing investigation at present, as judged by the investigator.

Treatment and study plan

Mepilex border post. op

Device

Mepilex border post op

Device

Primary outcomes

Minimize the Risk of the Development of Blistering.

Time frame: 7 days

Number of participants without blisters at study visit

Secondary outcomes

Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.

Time frame: 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
Comfort, Comformability, Acceptability of the Dressing

Time frame: 7 days
Pain Evaluation

Time frame: 7 days
Overall Cost Regarding Dressing Wear Time

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty

Acronym: MxB Po01

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Apr 26, 2013
Registry last updated: Sep 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.