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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
To investigate if there was any skin damage under the dressing from operation day to last visit.
The CORE Institute Gilbert
Gilbert, Arizona, United States
Number of Participants With Damage to the Incision and Surrounding Skin
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
Time frame: Daily visits, up to 7 days
Number of Participants With Leakage of the Dressing
Nurse/ Investigator evaluate: Leakage (No/Yes)
Time frame: Daily visits, up to 7 days
Number of Participants With Dressing Sticking to the Staples/Sutures
Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
Time frame: Daily visits, up to 7 days
Number of Participants With Bleeding Caused by Dressing Removal
Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
Time frame: Daily visits, up to 7 days
Participants' Dressing Wear Time (Days)
The number of days the dressing can stay on are evaluated
Time frame: 7 days
Number of Dressing Changes Per Subject
To evaluate the number of dressing changes per subject
Time frame: Daily visits, up to 7 days
Evaluation of the Dressing Capacity of Handling Blood
Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.
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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)
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
Time frame: Daily visits, up to 7 days