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

NCT ID: NCT03016078

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-04-07

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.

Conditions

Arthroplasties, Hip Replacement; Arthroplasties, Knee Replacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Mepilex Border Post-Op Ag

Intervention Type: DEVICE

To investigate if there was any skin damage under the dressing from operation day to last visit.

Interventions

Mepilex Border Post-Op Ag

To investigate if there was any skin damage under the dressing from operation day to last visit.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Myerthall, Dr

Role: PRINCIPAL_INVESTIGATOR

Center for Orthopedic Research and Education, The CORE Institute

Locations

The CORE Institute Gilbert

Gilbert, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MxB Po Ag 01

Identifier Type: -

Identifier Source: org_study_id