The purpose of this study is to document the incidence of allergic contact dermatitis (ACD) to silk fibroin and 2-octyl cyanoacrylate mesh dressings after open shoulder surgery, to identify differences in clinic utilization for complications related to silk fibroin and 2-octyl cyanoacrylate mesh dressings and to collect patient reported outcome measures (PROMs) related to patient comfort and satisfaction for silk fibroin and 2-octyl cyanoacrylate mesh dressings.
open shoulder procedure with Dr. James Gregory or Dr. Robert Fullick.
Prior documented medical adhesive contact allergy.
Negative pressure wound dressings.
Any procedure involving a wound problem at the planned surgical site.
Parallel
Silk fibroin (SYLKE)
DeviceSYLKE dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.
2-octyl cyanoacrylate mesh (Dermabond PRINEO)
DeviceDermabond PRINEO dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.
Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination
ACD will be diagnosed as erythema, with or without weeping or pruritus, in a geometric border at the surgical site and in the absence of fluctuance or purulence
Clinic utilization will be defined as the total number of additional patient communications or visits regarding dressings or wound complications
This will include telephone calls, electronic messages, additional office visits and additional ER visits.
Patients comfort as assessed by question 6 on the wound experience questionnaire
This is scored from 0(very uncomfortable) to 10 (very comfortable)
Patients satisfaction as assessed by question 7 on the wound experience questionnaire
This is scored from 0(very dissatisfied) to 10 (very satisfied)
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