Arthroplasties, Hip ReplacementNCT03016078
Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty
A study testing Mepilex Border Post-Op Ag in people with Arthroplasties, Hip Replacement and Arthroplasties, Knee Replacement, run by Molnlycke Health Care AB at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasties, Hip Replacement, Arthroplasties, Knee Replacement
- What is being tested?
- Mepilex Border Post-Op Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 7 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Available for a follow-up visit including dressing change 7 days after surgery
- Plan for elective primary hip or knee arthroplasty
- Plan for incision size ≤18 cm
- Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
- Undergoing elective primary arthroplasty of the hip or knee.
Who cannot join
- Known allergy/hypersensitivity to any of the components of the dressing
- Multi-trauma
- Undergoing arthroplasty due to tumor
- Previous incision at the same knee or same side of the hip
- Wound at the surgical site prior to surgery
- Neurological deficit of operated side (hemiplegia, etc.)
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- Documented skin disease at time of enrollment, as judged by the investigator
- Previously enrolled in the present investigation
- Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
- Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)
- Dressing size does not fit the incision area (>18 cm)
- Complications that would increase wound risks if investigational dressing is applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty
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.
Read the detailed description
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.
- Being tested
- Mepilex Border Post-Op Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Border Post-Op AgDevice
To investigate if there was any skin damage under the dressing from operation day to last visit.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Mepilex Border Post-Op Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Blistering (Yes/No) by visit
- Redness under dressing (Yes/No) by visit
- Redness outside dressing (Yes/No) by visit
- Maceration under dressing (Yes/No) by visit
- Maceration outside dressing (Yes/No) by visit
Measured: Daily visits, up to 7 days
Secondary outcomes (7)
Number of Participants With Leakage of the Dressing
Nurse/ Investigator evaluate: Leakage (No/Yes)
Measured: Daily visits, up to 7 days
Number of Participants With Dressing Sticking to the Staples/Sutures
Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
Measured: 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)
Measured: Daily visits, up to 7 days
Participants' Dressing Wear Time (Days)
The number of days the dressing can stay on are evaluated
Measured: 7 days
Number of Dressing Changes Per Subject
To evaluate the number of dressing changes per subject
Measured: 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.
Measured: 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
Measured: Daily visits, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion1 Apr 2017
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasties, Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Myerthall, Dr, Principal investigator, Center for Orthopedic Research and Education, The CORE Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016078
- Sponsor's protocol ID
- MxB Po Ag 01
- Status last verified
- Feb 2018
- First submitted
- 4 Jan 2017
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03016078
- Acronym / sponsor ID
- MxB Po Ag 01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mepilex Border Post-Op Ag Dressing | Other | Device: Mepilex Border Post-Op AgA soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Available for a follow-up visit including dressing change 7 days after surgery
- Plan for elective primary hip or knee arthroplasty
- Plan for incision size ≤18 cm
- Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
Key exclusion criteria (12 listed)
- Known allergy/hypersensitivity to any of the components of the dressing
- Multi-trauma
- Undergoing arthroplasty due to tumor
- Previous incision at the same knee or same side of the hip
- Wound at the surgical site prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepilex Border Post-Op AgTo investigate if there was any skin damage under the dressing from operation day to last visit. | Device | Mepilex Border Post-Op Ag Dressing |
Primary outcome
Number of Participants With Damage to the Incision and Surrounding Skin
Time frame: Daily visits, up to 7 days
The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: * Blistering (Yes/No) by visit * Redness under dressing (Yes/No) by visit * Redness outside dressing (Yes/No) by visit * Maceration under dressing (Yes/No) by visit * Maceration outside dressing (Yes/No) by visit
7 secondary outcomes
Number of Participants With Leakage of the Dressing
Time frame: Daily visits, up to 7 days
Number of Participants With Dressing Sticking to the Staples/Sutures
Time frame: Daily visits, up to 7 days
Number of Participants With Bleeding Caused by Dressing Removal
Time frame: Daily visits, up to 7 days
Participants' Dressing Wear Time (Days)
Time frame: 7 days
Number of Dressing Changes Per Subject
Time frame: Daily visits, up to 7 days
Evaluation of the Dressing Capacity of Handling Blood
Time frame: 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)
Time frame: Daily visits, up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Myerthall, Dr principal investigator
Center for Orthopedic Research and Education, The CORE Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Border Post-Op Ag in people with Arthroplasties, Hip Replacement and Arthroplasties, Knee Replacement, run by Molnlycke Health Care AB at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Damage to the Incision and Surrounding Skin (time frame: Daily visits, up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.