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Post Market Clinical Follow-up Study

NCT ID: NCT01841567

Last Updated: 2014-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Hip or Knee Surgery

Keywords

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hip knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dressing

Group Type OTHER

Mepilex border post. op

Intervention Type DEVICE

Mepilex border post op

Intervention Type DEVICE

Interventions

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Mepilex border post. op

Intervention Type DEVICE

Mepilex border post op

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Molnlycke Health Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kourosh Zarghooni, Dr. Med

Role: PRINCIPAL_INVESTIGATOR

University Hospital Koln

Locations

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universitätsklinikum Köln

Cologne, Köln, Germany

Site Status

Countries

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Germany

Other Identifiers

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MxB Po01

Identifier Type: -

Identifier Source: org_study_id