Allergic Contact Dermatitis (ACD)NCT07868900
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
A study testing Dermabond PRINEO and Silk fibroin in people with Allergic Contact Dermatitis (ACD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Contact Dermatitis (ACD)
- What is being tested?
- Dermabond PRINEO and Silk fibroin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary total hip arthroplasty performed by Dr. Rodriguez, Dr. Freedhand or Dr. Shahi
Who cannot join
- Prior documented medical adhesive contact allergy.
- Negative pressure wound dressings.
- Any procedure involving a wound problem at the planned surgical site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77479
David Rodriguez-Quintana, MD, (713) 486-7500, David.RodriguezQuintana@uth.tmc.edu
Ethan Sij, 940-399-3314, Ethan.W.Sij@uth.tmc.edu
About this study
Official title: A Randomized Controlled Trial to Evaluate Wound Complications After Primary Total Hip Arthroplasty Using Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh
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.
- Conditions
- Allergic Contact Dermatitis (ACD)
- Being tested
- Dermabond PRINEO, Silk fibroin
- Keywords
- total hip arthroplasty
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond PRINEODevice
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.
Silk fibroinDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dermabond PRINEO skin closure system | Active comparator | Not described Receives: Device: Dermabond PRINEO |
| Silk fibroin wound dressing | Experimental | Not described Receives: Device: Silk fibroin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the time of dressing removal about 10-14 days after surgery
Number of participants with acute wound dehiscence resulting in reoperation
Measured: within 6 weeks of index procedure
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 2-4 weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact Dermatitis (ACD)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rodriguez-Quintana, The University of Texas Health Science Center, Houston
- Investigators
- David Rodriguez-Quintana, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868900
- Sponsor's protocol ID
- HSC-MS-26-0703
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Wound Complications After Primary Total Hip Arthroplasty Using Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh
- ClinicalTrials.gov ID
- NCT07868900
- Acronym / sponsor ID
- HSC-MS-26-0703
- Conditions
- Allergic Contact Dermatitis (ACD)
- Keywords
- total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermabond PRINEO skin closure system | Active comparator | Device: Dermabond PRINEO |
| Silk fibroin wound dressing | Experimental | Device: Silk fibroin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary total hip arthroplasty performed by Dr. Rodriguez, Dr. Freedhand or Dr. Shahi
Key exclusion criteria (3 listed)
- Prior documented medical adhesive contact allergy.
- Negative pressure wound dressings.
- Any procedure involving a wound problem at the planned surgical site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermabond PRINEOParticipants 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. | Device | Dermabond PRINEO skin closure system |
| Silk fibroinParticipants 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. | Device | Silk fibroin wound dressing |
Primary outcome
Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination by a blinded observer at dressing removal
Time frame: 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
Time frame: within 6 weeks of index procedure
3 secondary outcomes
Clinic utilization as assessed by the the total number of additional patient communications or visits regarding dressings or wound complications.
Time frame: 6-8 weeks after the operation
Patient overall comfort as assessed by question 6 on the Patient Reported Outcomes (PROMs) questionnaire .
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 .
Time frame: 2-4 weeks after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Allergic Contact Dermatitis (ACD)
Not yet recruitingObservational study
Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool
Allergic Contact Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Rodriguez-Quintana, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermabond PRINEO and Silk fibroin in people with Allergic Contact Dermatitis (ACD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Rodriguez-Quintana, MD ((713) 486-7500, David.RodriguezQuintana@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination by a blinded observer at dressing removal (time frame: At the time of dressing removal about 10-14 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.