An interventional study of Dermabond PRINEO and Silk fibroin in Allergic Contact Dermatitis (ACD), sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
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.
52 studies on the registry are indexed under Dermatitis, Allergic Contact; 12 are open to participants now.
This study's planned enrollment of 350 is above the median of 48 across 40 interventional studies indexed under Dermatitis, Allergic Contact.
Browse Dermatitis, Allergic Contact studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
Device: Dermabond PRINEO
Device: Silk fibroin
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.
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.
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
Time frame: At the time of dressing removal about 10-14 days after surgery
Number of participants with acute wound dehiscence resulting in reoperation
Time frame: within 6 weeks of index procedure
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.
Time frame: 6-8 weeks after the operation
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
Time frame: 2-4 weeks after the operation
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
Time frame: 2-4 weeks after the operation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 15 interventional studies with no phase under Dermatitis, Allergic Contact, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 21. This study's planned 12 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Dermatitis, Allergic Contact →
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