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

Not Applicable

Completed

Conditions: Arthroplasties, Hip Replacement
Arthroplasties, Knee Replacement

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Mepilex Border Post-Op Ag Dressing	Mepilex Border Post-Op Ag	A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties

Primary Outcome Measures

Name	Time	Method
Number of Participants With Damage to the Incision and Surrounding Skin	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

Name	Time	Method
Number of Participants With Dressing Sticking to the Staples/Sutures	Daily visits, up to 7 days	Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
Evaluation of the Dressing Capacity of Handling Blood	Daily visits, up to 7 days	Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.
Participants' Dressing Wear Time (Days)	7 days	The number of days the dressing can stay on are evaluated
Number of Participants With Bleeding Caused by Dressing Removal	Daily visits, up to 7 days	Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
Number of Dressing Changes Per Subject	Daily visits, up to 7 days	To evaluate the number of dressing changes per subject
Number of Participants With Leakage of the Dressing	Daily visits, up to 7 days	Nurse/ Investigator evaluate: Leakage (No/Yes)
Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)	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