Clinical trial NCT03016078: Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasties, Hip Replacement
Arthroplasties, Knee Replacement
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2017-01-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Damage to the Incision and Surrounding Skin
timeFrame: Daily visits, up to 7 days
Secondary outcomes:
measure: Number of Participants With Leakage of the Dressing
timeFrame: Daily visits, up to 7 days
measure: Number of Participants With Dressing Sticking to the Staples/Sutures
timeFrame: Daily visits, up to 7 days
measure: Number of Participants With Bleeding Caused by Dressing Removal
timeFrame: Daily visits, up to 7 days
measure: Participants' Dressing Wear Time (Days)
timeFrame: 7 days
measure: Number of Dressing Changes Per Subject
timeFrame: Daily visits, up to 7 days
measure: Evaluation of the Dressing Capacity of Handling Blood
timeFrame: Daily visits, up to 7 days
measure: Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)
timeFrame: Daily visits, up to 7 days
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: The CORE Institute Gilbert
state: Arizona
Study officials:
affiliation: Center for Orthopedic Research and Education, The CORE Institute
name: Steven Myerthall, Dr
role: PRINCIPAL_INVESTIGATOR
References: