Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03016078|
Recruitment Status : Completed
First Posted : January 10, 2017
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasties, Hip Replacement Arthroplasties, Knee Replacement||Device: Mepilex Border Post-Op Ag||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||April 1, 2017|
|Actual Study Completion Date :||April 7, 2017|
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
Device: Mepilex Border Post-Op Ag
To investigate if there was any skin damage under the dressing from operation day to last visit.
- 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
- Number of Participants With Leakage of the Dressing [ Time Frame: Daily visits, up to 7 days ]Nurse/ Investigator evaluate: Leakage (No/Yes)
- 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)
- 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)
- Participants' Dressing Wear Time (Days) [ Time Frame: 7 days ]The number of days the dressing can stay on are evaluated
- Number of Dressing Changes Per Subject [ Time Frame: Daily visits, up to 7 days ]To evaluate the number of dressing changes per subject
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016078
|United States, Arizona|
|The CORE Institute Gilbert|
|Gilbert, Arizona, United States, 85297|
|Principal Investigator:||Steven Myerthall, Dr||Center for Orthopedic Research and Education, The CORE Institute|