Hip or Knee Surgery
Conditions
Keywords
hip, knee
Brief summary
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).
Interventions
DEVICEMepilex border post. op
DEVICEMepilex border post op
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimize the Risk of the Development of Blistering. | 7 days | Number of participants without blisters at study visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort, Comformability, Acceptability of the Dressing | 7 days | — |
| Pain Evaluation | 7 days | — |
| Overall Cost Regarding Dressing Wear Time | 7 days | — |
| Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing. | 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dressing Mepilex border post. op
Mepilex border post op | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
Baseline characteristics
| Characteristic | Dressing |
|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment Germany | 60 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 2 / 60 |
Outcome results
Primary
Minimize the Risk of the Development of Blistering.
Number of participants without blisters at study visit
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dressing | Minimize the Risk of the Development of Blistering. | 60 participants |
Secondary
Comfort, Comformability, Acceptability of the Dressing
Time frame: 7 days
Secondary
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.
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
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dressing | Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing. | 60 participants |
Secondary
Overall Cost Regarding Dressing Wear Time
Time frame: 7 days
Secondary
Pain Evaluation
Time frame: 7 days