N/A
N=21
Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty
Arthroplasties, Hip Replacement · Arthroplasties, Knee Replacement
Bottom Line
View on ClinicalTrials.gov: NCT03016078 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Number of Participants With Damage to the Incision and Surrounding Skin — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepilex Border Post-Op Ag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Damage to the Incision and Surrounding Skin |
0; 0; 0; 0; 0; 5 | — |
| SECONDARY Number of Participants With Leakage of the Dressing |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Dressing Sticking to the Staples/Sutures |
0; 0; 0 | — |
| SECONDARY Number of Participants With Bleeding Caused by Dressing Removal |
0; 0; 0 | — |
| SECONDARY Participants' Dressing Wear Time (Days) |
6.35 | — |
| SECONDARY Number of Dressing Changes Per Subject |
1.00 | — |
| SECONDARY Evaluation of the Dressing Capacity of Handling Blood |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change) |
3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03016078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.