This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds.
This is a randomized, controlled single-blind pilot study to evaluate the safety and performance of AC5 following excision of lesions from the trunk or upper limbs under local anesthetic, in patients currently prescribed or not prescribed antiplatelet monotherapy. Each patient had sequential shave excision of two lesions (one treatment, one Control) at the same sitting. The sequence of wound treatment (AC5 first or Control first) was randomized. Study and Control treatments were administered immediately after lesion excision, followed by determination of time to hemostasis (TTH), and application of an occlusive water-resistant dressing
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
46
Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient
University College Hospital
Galway, Ireland
Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up
Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up. Systemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up.
Time frame: 30 Days Post Procedure
Median Time to Hemostasis (Seconds)
Measure of time from application of treatment or control to the wound, to bleeding cessation
Time frame: At time of application (Day 0)
Time to Hemostasis in Seconds Per Square Centimeter Wound Area
Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area
Time frame: At time of application (Day 0)
Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30
The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and \>40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 7 and 30 Days Post Procedure