Allergic Contact Dermatitis (ACD)
Conditions
Keywords
total hip arthroplasty
Brief summary
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.
Interventions
DEVICEDermabond PRINEO
Participants 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.
DEVICESilk fibroin
Participants 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary total hip arthroplasty performed by Dr. Rodriguez, Dr. Freedhand or Dr. Shahi
Exclusion criteria
* Prior documented medical adhesive contact allergy. * Negative pressure wound dressings. * Any procedure involving a wound problem at the planned surgical site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination by a blinded observer at dressing removal | At the time of dressing removal about 10-14 days after surgery | 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 | within 6 weeks of index procedure | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic utilization as assessed by the the total number of additional patient communications or visits regarding dressings or wound complications. | 6-8 weeks after the operation | 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 . | 2-4 weeks after the operation | 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 . | 2-4 weeks after the operation | This will be measured on a linear scale from 0(very dissatisfied) to 10 (very satisfied), higher number indicating better outcome |
Countries
United States
Contacts
CONTACTDavid Rodriguez-Quintana, MD
CONTACTEthan Sij
PRINCIPAL_INVESTIGATORDavid Rodriguez-Quintana, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed