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

February 13, 2018 updated by: Molnlycke Health Care AB

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.

Study Overview

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

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Gilbert, Arizona, United States, 85297
        • The CORE Institute Gilbert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Steven Myerthall, Dr, Center for Orthopedic Research and Education, The CORE Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 7, 2017

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 8, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

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

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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