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Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016078
Recruitment Status : Completed
First Posted : January 10, 2017
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Brief 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.

Condition or disease Intervention/treatment
Arthroplasties, Hip Replacement Arthroplasties, Knee Replacement Device: Mepilex Border Post-Op Ag

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Participants With Leakage of the Dressing [ Time Frame: Daily visits, up to 7 days ]
    Nurse/ Investigator evaluate: Leakage (No/Yes)

  2. 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)

  3. 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)

  4. Participants' Dressing Wear Time (Days) [ Time Frame: 7 days ]
    The number of days the dressing can stay on are evaluated

  5. Number of Dressing Changes Per Subject [ Time Frame: Daily visits, up to 7 days ]
    To evaluate the number of dressing changes per subject

  6. 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.

  7. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Available for a follow-up visit including dressing change 7 days after surgery
  3. Plan for elective primary hip or knee arthroplasty
  4. Plan for incision size ≤18 cm
  5. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
  6. Undergoing elective primary arthroplasty of the hip or knee.

Exclusion Criteria

  1. Known allergy/hypersensitivity to any of the components of the dressing
  2. Multi-trauma
  3. Undergoing arthroplasty due to tumor
  4. Previous incision at the same knee or same side of the hip
  5. Wound at the surgical site prior to surgery
  6. Neurological deficit of operated side (hemiplegia, etc.)
  7. Documented skin disease at time of enrollment, as judged by the investigator
  8. Previously enrolled in the present investigation
  9. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
  10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)
  11. Dressing size does not fit the incision area (>18 cm)
  12. Complications that would increase wound risks if investigational dressing is applied

Information from the National Library of Medicine

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


Locations
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United States, Arizona
The CORE Institute Gilbert
Gilbert, Arizona, United States, 85297
Sponsors and Collaborators
Molnlycke Health Care AB
  Study Documents (Full-Text)

Documents provided by Molnlycke Health Care AB:
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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT03016078    
Other Study ID Numbers: MxB Po Ag 01
First Posted: January 10, 2017    Key Record Dates
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018
Last Verified: February 2018