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The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.
The secondary objectives are to evaluate:
A prospective, randomized clinical investigation will be conducted at two to three sites in Belgium and Sweden.
Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation.
100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment randomization. Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in a ratio of 1:1 provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Aquacel Surgical | Active Comparator | Aquacel Surgical is a sterile, one piece post-operative dressing from Convatec. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. |
|
| Device Mepilex Border Post-Op | Experimental | Post-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: Aquacel Surgical | Device | Post-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Scale range from 0 (no dressing failure) to 7 ( complete dressing failure). | 0-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dressings Adherence to the Staples/Sutures | Dressings adherence to the staples/sutures? Yes/No | 0-5 days |
| Itching Feeling Under the Dressing | Itching feeling under the dressing? Yes/No |
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Inclusion Criteria, enrolment phase
Inclusion Criteria, randomization phase
1. Undergoing elective primary arthroplasty of the hip or knee
Exclusion Criteria,enrolment phase
Exclusion Criteria, randomization phase
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gent, Belgium | Ghent | 9000 Gent | Belgium | |||
| Medisch Centrum Latem |
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118 subjects were enrolled and 113 subjects were randomized, Out of the 113 randomized subjects. Screening failure, IP never applied, inclusion criteria inclusion criteria 4 not met.=5 Not included in the analysis The patient signed IC after data been entered into the eCRF. Excluded from the analysis=5
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Mepilex Border Post-Op | Post-operative all-in-one self-adherent soft silicone coated foam dressing. Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing |
| FG001 | Device Aquacel Surgical | Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec. Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device Mepilex Border Post-Op | Post-operative all-in-one self-adherent soft silicone coated foam dressing. Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing |
| BG001 | Device Aquacel Surgical |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Scale range from 0 (no dressing failure) to 7 ( complete dressing failure). | Posted | Number | participants | 0-5 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Mepilex Border Post-Op | Post-operative all-in-one self-adherent soft silicone coated foam dressing. Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Hilde Beele | Universitair Ziekenhuis Gent | +32 9 332 21 11 | Hilde.Beele@uzgent.be |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Experimental: Mepilex Border Post-Op | Device | Aquacel Surgical is a sterile, one piece post-operative dressing.Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. |
|
| 0-5 days |
| Patients Satisfaction With Wearing the Dressing | 4 point rating scale ( poor, good, very good,excellent) | 0-5 days |
| Nurses/Doctors Satisfaction With Applying the Dressing | 4 point rating scale ( poor, good, very good,excellent) | 0-5 days |
| Patients Mobility After Operation | 4 point rating scale ( poor, good, very good,excellent) | 0-5 days |
| Local/Systemic Infection | Local/systemic infection? Yes/No | 0-5 days |
| Pain Level Before and During Dressing Removal | Different adhesive on the dressings, can any difference be identified during dressing removal. Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable. | Day 7 |
| Sint-Martens-Latem |
| 9830 |
| Belgium |
| Södersjukhuset | Stockholm | 118 83 | Sweden |
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec. Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of surgery | Number | participants |
|
| Skin type | Number | participants |
|
|
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| Secondary | Dressings Adherence to the Staples/Sutures | Dressings adherence to the staples/sutures? Yes/No | Posted | Number | participants | 0-5 days |
|
|
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| Secondary | Itching Feeling Under the Dressing | Itching feeling under the dressing? Yes/No | Posted | Number | participants | 0-5 days |
|
|
|
| Secondary | Patients Satisfaction With Wearing the Dressing | 4 point rating scale ( poor, good, very good,excellent) | Posted | Number | participants | 0-5 days |
|
|
|
| Secondary | Nurses/Doctors Satisfaction With Applying the Dressing | 4 point rating scale ( poor, good, very good,excellent) | Posted | Number | participants | 0-5 days |
|
|
|
| Secondary | Patients Mobility After Operation | 4 point rating scale ( poor, good, very good,excellent) | Posted | Number | participants | 0-5 days |
|
|
|
| Secondary | Local/Systemic Infection | Local/systemic infection? Yes/No | Posted | Number | participants | 0-5 days |
|
|
|
| Secondary | Pain Level Before and During Dressing Removal | Different adhesive on the dressings, can any difference be identified during dressing removal. Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable. | Posted | Mean | Standard Deviation | units on a scale | Day 7 |
|
|
|
| 0 |
| 53 |
| 22 |
| 53 |
| EG001 | Device Aquacel Surgical | Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec. Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing | 0 | 50 | 15 | 50 |
| Obstipation | Surgical and medical procedures |
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| Allergic reaction | Surgical and medical procedures |
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| Dizziness | Surgical and medical procedures |
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| Elevated glucose levels | Surgical and medical procedures |
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| Excema, medication related | Surgical and medical procedures |
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| Fever | Surgical and medical procedures |
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| Insomnia | Surgical and medical procedures |
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| Itching | Surgical and medical procedures |
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| Low hemoglobine level | Surgical and medical procedures |
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| Skin allergy | Surgical and medical procedures |
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| Confusion | Surgical and medical procedures |
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| Very good |
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| Excellent |
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| Very Good |
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| Excellent |
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| Very good |
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| Excellent |
|