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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

Tracking Information
First Submitted Date  ICMJE January 4, 2017
First Posted Date  ICMJE January 10, 2017
Results First Submitted Date  ICMJE January 16, 2018
Results First Posted Date  ICMJE February 14, 2018
Last Update Posted Date February 14, 2018
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2017)
To evaluate the skin damage under the dressing [ Time Frame: 7 days ]
  • Nurse/Investigator evaluate: Blistering (No/Yes)
  • Nurse/Investigator evaluate: Redness (No/Yes)
  • Nurse/ Investigator evaluate: Maceration (No/Yes)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2017)
  • To evaluate leakage of the dressing [ Time Frame: 7 days ]
    Nurse/ Investigator evaluate: Leakage (No/Yes)
  • To evaluate shower ability [ Time Frame: 7 days ]
    Nurse/ Investigator evaluate: Shower ability (No/Yes)
  • To evaluate if the dressing sticks to the staples/sutures [ Time Frame: 7 days ]
    Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
  • To evaluate if any bleeding caused by dressing removal [ Time Frame: 7 days ]
    Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
  • To evaluate the dressing wear time (days) [ Time Frame: 7 days ]
    The number of days the dressing can stay on are evaluated
  • To evaluate the number of dressing changes [ Time Frame: 7 days ]
    Number of dressing changes are evaluated
  • To evaluate the dressing capacity of handling blood [ Time Frame: 7 days ]
    Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.
  • Evaluate if any residuals of the dressing material in the wound or surrounding skin [ Time Frame: 7 days ]
    Nurse/ Investigator evaluate with No/Yes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthroplasties, Hip Replacement
  • Arthroplasties, Knee Replacement
Intervention  ICMJE Device: Mepilex Border Post-Op Ag
To investigate if there was any skin damage under the dressing from operation day to last visit.
Study Arms  ICMJE 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
Intervention: Device: Mepilex Border Post-Op Ag
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2017)
20
Actual Study Completion Date  ICMJE April 7, 2017
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03016078
Other Study ID Numbers  ICMJE MxB Po Ag 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Molnlycke Health Care AB
Study Sponsor  ICMJE Molnlycke Health Care AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Myerthall, Dr Center for Orthopedic Research and Education, The CORE Institute
PRS Account Molnlycke Health Care AB
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP