The purpose of this study is to document the incidence of allergic contact dermatitis (ACD) to silk fibroin and 2-octyl cyanoacrylate mesh dressings, to document the incidence of acute wound dehiscence requiring reoperation after application of silk fibroin and 2-octyl cyanoacrylate mesh dressings, 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 after total hip arthroplasty.
primary total hip arthroplasty performed by Dr. Rodriguez, Dr. Freedhand or Dr. Shahi
Prior documented medical adhesive contact allergy.
Negative pressure wound dressings.
Any procedure involving a wound problem at the planned surgical site.
Parallel
Dermabond PRINEO
DeviceParticipants will have the Dermabond PRINEO wound dressing applied after surgery and will undergo standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound. Photos of the surgical wound will be uploaded to the patient's electronic medical record during dressing removal.
Silk fibroin
DeviceParticipants will have the Silk fibroin wound dressing applied after surgery and will undergo standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound. Photos of the surgical wound will be uploaded to the patient's electronic medical record during dressing removal.
Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination by a blinded observer at dressing removal
ACD includes erythema, with or without weeping or pruritus, in a geometric border at the surgical site with absence of fluctuance or purulence
Number of participants with acute wound dehiscence resulting in reoperation
Clinic utilization as assessed by the 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.
Patient overall comfort as assessed by question 6 on the Patient Reported Outcomes (PROMs) questionnaire .
This will be measured on a linear scale from 0(very uncomfortable) to 10 (very comfortable), higher number indicating better outcome
Patient satisfaction with the dressing as assessed by question 7 on the Patient Reported Outcomes (PROMs) questionnaire .
This will be measured on a linear scale from 0(very dissatisfied) to 10 (very satisfied), higher number indicating better outcome
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
