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The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.
This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA).
The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Border Post-Op Ag Dressing | Other | A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Border Post-Op Ag | Device | To investigate if there was any skin damage under the dressing from operation day to last visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Damage to the Incision and Surrounding Skin | The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:
| Daily visits, up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Leakage of the Dressing | Nurse/ Investigator evaluate: Leakage (No/Yes) | Daily visits, up to 7 days |
| Number of Participants With Dressing Sticking to the Staples/Sutures |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Steven Myerthall, Dr | Center for Orthopedic Research and Education, The CORE Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The CORE Institute Gilbert | Gilbert | Arizona | 85297 | United States |
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Investigation period: Feb 2017 - March 2017. The study was conducted on 21 enrolled subjects at one site in the US. Subjects included were 18 years, and above, undergoing elective primary hip or knee arthroplasty.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Border Post-Op Ag Dressing | A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All variables measured at baseline were summarised for the ITT and PP populations using appropriate summary statistics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Border Post-Op Ag Dressing | A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Damage to the Incision and Surrounding Skin | The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:
| The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits. | Posted | Count of Participants | Participants | Daily visits, up to 7 days |
|
Average of one Week
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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 | The Study Group | Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness at border of derssing | Skin and subcutaneous tissue disorders | Systematic Assessment | Study subject had a distinctive border of redness where the silicone border was present. Subject denied any itching or pain at the incision site, but the PI confirmed it was an AE with a possible relation ADE. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Research Director | Mölnlycke Health Care | +46 31 722 30 00 | info@monlycke.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2016 | Jan 15, 2018 | Prot_SAP_000.pdf |
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Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
| Daily visits, up to 7 days |
| Number of Participants With Bleeding Caused by Dressing Removal | Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes) | Daily visits, up to 7 days |
| Participants' Dressing Wear Time (Days) | The number of days the dressing can stay on are evaluated | 7 days |
| Number of Dressing Changes Per Subject | To evaluate the number of dressing changes per subject | Daily visits, up to 7 days |
| Evaluation of the Dressing Capacity of Handling Blood | Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale. | Daily visits, up to 7 days |
| Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change) | Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change). Nurse/ Investigator evaluate with No/Yes | Daily visits, up to 7 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Blistering | Number | Number of blisters |
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| Secondary | Number of Participants With Leakage of the Dressing | Nurse/ Investigator evaluate: Leakage (No/Yes) | The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits. | Posted | Count of Participants | Participants | Daily visits, up to 7 days |
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| Secondary | Number of Participants With Dressing Sticking to the Staples/Sutures | Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes) | The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits. | Posted | Count of Participants | Participants | Daily visits, up to 7 days |
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| Secondary | Number of Participants With Bleeding Caused by Dressing Removal | Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes) | The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.. | Posted | Count of Participants | Participants | Daily visits, up to 7 days |
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| Secondary | Participants' Dressing Wear Time (Days) | The number of days the dressing can stay on are evaluated | The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits. | Posted | Mean | Standard Deviation | days | 7 days |
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| Secondary | Number of Dressing Changes Per Subject | To evaluate the number of dressing changes per subject | The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits. | Posted | Mean | Standard Deviation | Number of dressing changes per subject | Daily visits, up to 7 days |
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| Secondary | Evaluation of the Dressing Capacity of Handling Blood | Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale. | The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits. | Posted | Count of Participants | Participants | Daily visits, up to 7 days |
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| Secondary | Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change) | Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change). Nurse/ Investigator evaluate with No/Yes | The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits. | Posted | Count of Participants | Participants | Daily visits, up to 7 days |
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| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
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| Leakage visit 5 |
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| Leakage visit 6 |
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| Dressing sticks to the staples visit 6 |
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| Bleeding caused by the dressing removal visit 6 |
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| Poor visit 6 |
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| Good visit 3 |
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| Good visit 5 |
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| Good visit 6 |
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| Very good visit 3 |
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| Very good visit 5 |
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| Very good visit 6 |
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| Excellent visit 3 |
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| Excellent visit 5 |
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| Excellent visit 6 |
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| Not applicable visit 6 |
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