- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03016078
Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Gilbert, Arizona, United States, 85297
- The CORE Institute Gilbert
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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.)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
To investigate if there was any skin damage under the dressing from operation day to last visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Daily visits, up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Leakage of the Dressing
Time Frame: Daily visits, up to 7 days
|
Nurse/ Investigator evaluate: Leakage (No/Yes)
|
Daily visits, up to 7 days
|
Number of Participants With Dressing Sticking to the Staples/Sutures
Time Frame: Daily visits, up to 7 days
|
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
Time Frame: Daily visits, up to 7 days
|
Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
|
Daily visits, up to 7 days
|
Participants' Dressing Wear Time (Days)
Time Frame: 7 days
|
The number of days the dressing can stay on are evaluated
|
7 days
|
Number of Dressing Changes Per Subject
Time Frame: Daily visits, up to 7 days
|
To evaluate the number of dressing changes per subject
|
Daily visits, up to 7 days
|
Evaluation of the Dressing Capacity of Handling Blood
Time Frame: Daily visits, up to 7 days
|
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)
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). Nurse/ Investigator evaluate with No/Yes |
Daily visits, up to 7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven Myerthall, Dr, Center for Orthopedic Research and Education, The CORE Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MxB Po Ag 01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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