Overview
This study investigates the effect of different dressings on skin pH when applied to a simulated skin fold environment.
Description
This study evaluates the impact of various dressings on skin pH when applied to a simulated skin fold environment. To replicate the occlusive conditions commonly found in skin folds, a non-breathable film will be placed over the dressings, maintaining occlusion for approximately 24 hours.
Skin pH measurements will be taken during two separate visits: once before dressing application and again after approximately 24 hours of wear time. Both measurements will be conducted on the same location on the forearms of healthy participants. The goal is to investigate how different dressings influence skin pH under occlusive conditions.
Eligibility
Inclusion Criteria:
- Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
- Between 14 and 70 years old at the time of surgery.
- Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
- Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
- If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:
- International Knee Documentation Committee (IKDC)
- Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
- Patient-Reported Outcomes Measurement Information System (PROMIS-10)
- Tegner Activity Scale (TAS)
- Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
- Positive diagnostic imaging by MRI at baseline indicating an ACL tear
Exclusion Criteria:
- Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
- Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
- Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
- Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.
