Allergic Contact DermatitisNCT06957444
Rate of Allergic Contact Dermatitis and Cosmetic Outcomes
A study testing Sylke Adhesive Dressing, Exofin Skin Glue and Suture Strip Plus in people with Allergic Contact Dermatitis and Osteoarthritis, Hip, run by West Virginia University at 1 site in United States.
Trial summary
The patients from the Department of Orthopaedics Center for Joint Replacement will be asked to participate in the study. These patients will be randomized to one of three wound closure products, Sylke adhesive dressing, Exofin skin glue, or Suture Strip Plus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic Contact Dermatitis, Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- Sylke Adhesive Dressing, Exofin Skin Glue and Suture Strip Plus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to Sep 2028
- Phase
- Interventional
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to sign the informed consent
- Patients presenting to the WVU Medicine Center for Joint Replacement who have a primary TKA or THA surgery scheduled
- Patients with surgical wounds closed by 2-0 vicryl and barbed, running v-loc suture (assessed in OR)
- Active MyChart account and the ability to take and upload a photo in that system
Who cannot join
- Patients scheduled for a revision THA or revision TKA
- THA used for treatment of a fracture
- Patients participating in other studies that might have involve medications such as antibiotics
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
West Virginia University
Morgantown, West Virginia, 26505
About this study
Official title: Rate of Allergic Contact Dermatitis and Cosmetic Outcomes for Three Wound Closure Techniques in Joint Arthroplasty Patients: A Randomized, Controlled Trial
The patients from the Department of Orthopaedics Center for Joint Replacement will be asked to participate in the study. These patients will be randomized to one of three wound closure products, Sylke adhesive dressing, Exofin skin glue, or Suture Strip Plus. Participants will be asked to take a photograph of the incision 4 days after surgery to submit via MyChart for review by the WVU Department of Dermatology Team. All patients will be evaluated at their regular 2-week, 6-week, and 3-month post-operative visits where clinical photographs will be submitted for independent review by the WVU Department of Dermatology Team to assess outcomes.
- Being tested
- Sylke Adhesive Dressing, Exofin Skin Glue, Suture Strip Plus
- Medical subject headings
- Dermatitis, Allergic Contact, Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sylke Adhesive DressingProcedure or surgery
Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.
Exofin Skin GlueProcedure or surgery
2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.
Suture Strip PlusProcedure or surgery
Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Sylke Adhesive Dressing | Active comparator | Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty Receives: Procedure: Sylke Adhesive Dressing |
| Exofin Skin Glue | Active comparator | Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty Receives: Procedure: Exofin Skin Glue |
| Suture Strip Plus | Active comparator | Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty Receives: Procedure: Suture Strip Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of allergic contact dermatitis (4 Days Post Op)
Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis:
Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.
Measured: 4 Days Post-Op
Rate of allergic contact dermatitis (2 Weeks Post Op)
Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis:
Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.
Measured: 2 Weeks Post-Op
Rate of allergic contact dermatitis (6 Weeks Post Op)
Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis:
Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.
Measured: 6 Weeks Post-Op
Rate of allergic contact dermatitis (3 Months Post Op)
Percentage of participants exhibiting allergic contact dermatitis as determined by using the International Contact Dermatitis Research Group (ICDRG) scale with any reaction including and above "Weak Positive" being included in this rate of allergic contact dermatitis:
Negative (0): No reaction. Doubtful (+?): Slight erythema (redness) without infiltration. Weak positive (+): Erythema, infiltration, possibly papules. Strong positive (++): Erythema, infiltration, papules, vesicles. Extreme positive (+++): Intense erythema, infiltration, coalescing vesicles, bullous reaction.
Measured: 3 Months Post-Op
Secondary outcomes (4)
Difference in Cosmetic Outcome (4 Days Post-Op)
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.
Measured: 4 Days Post-Op
Difference in Cosmetic Outcome (2 Weeks Post-Op)
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.
Measured: 2 Weeks Post-Op
Difference in Cosmetic Outcome (6 Weeks Post-Op)
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.
Measured: 6 Weeks Post-Op
Difference in Cosmetic Outcome (3 Months Post-Op)
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated tool used to assess the quality of postoperative scars. The SCAR scale measures postoperative scar cosmesis with scores ranging from 0 (best possible scar) to 15 (worst possible scar). The assessment includes both clinician and patient items, ensuring a comprehensive evaluation.
Measured: 3 Months Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start13 Oct 2025
- Primary completionMay 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Allergic Contact DermatitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Frye, West Virginia University
- Investigators
- Benjamin Frye, MD, Principal investigator, West Virginia University Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957444
- Sponsor's protocol ID
- 2503134113
- Status last verified
- May 2026
- First submitted
- 25 Apr 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao E, Tarkin IS, Moloney GB. Subcuticular Barbed Suture and Skin Glue Wound Closure Decreases Reoperation and Length of Stay in Geriatric Hip Fractures When Compared With Staples. J Am Acad Orthop Surg Glob Res Rev. 2021 Oct 4;5(10):e21.00205. doi: 10.5435/JAAOSGlobal-D-21-00205.
PubMed 34605793Ali E, Makhdom AM. Association of Surgical Adhesive and Glue System With Incidence of Allergic Dermatitis Post Unilateral and Staged Bilateral Total Knee Arthroplasty. Cureus. 2024 Apr 23;16(4):e58827. doi: 10.7759/cureus.58827. eCollection 2024 Apr.
PubMed 38654960Ricciardo BM, Nixon RL, Tam MM, Radic RR, Ricciardo BJ. Allergic Contact Dermatitis to Dermabond Prineo After Elective Orthopedic Surgery. Orthopedics. 2020 Nov 1;43(6):e515-e522. doi: 10.3928/01477447-20200827-01. Epub 2020 Sep 3.
PubMed 32882052Pannu CD, Farooque Md K. Allergic Contact Dermatitis to Octyl Cyanoacrylate Skin Glue After Surgical Wound Closure: A Systematic Review. Dermatitis. 2024 Sep-Oct;35(5):443-466. doi: 10.1089/derm.2023.0342. Epub 2024 Feb 21.
PubMed 38386590Kim D, Lee NR, Park SY, Jun M, Lee K, Kim S, Park CS, Liu KH, Choi EH. As in Atopic Dermatitis, Nonlesional Skin in Allergic Contact Dermatitis Displays Abnormalities in Barrier Function and Ceramide Content. J Invest Dermatol. 2017 Mar;137(3):748-750. doi: 10.1016/j.jid.2016.10.034. Epub 2016 Nov 5. No abstract available.
PubMed 27826010Zhang W, Xu J, Qu S, Peng H. The impact of allergic contact dermatitis on the inflammatory response and repair in wound healing process. Front Med (Lausanne). 2025 Feb 19;12:1524198. doi: 10.3389/fmed.2025.1524198. eCollection 2025.
PubMed 40046929Rouhani DS, Singh NK, Chao JJ, Almutairi A, Seradj MH, Badowski-Platz R, Toranto JD, Mofid MM. Superiority of a Silk Surgical Site Wound Closure Device over Synthetic Dressings. Plast Reconstr Surg. 2024 Dec 1;154(6):1233-1244. doi: 10.1097/PRS.0000000000011316. Epub 2024 Feb 7.
PubMed 38330504Rouhani DS, Singh NK, Chao JJ, Almutairi A, Badowski-Platz R, Seradj MH, Mofid MM. Silk Bioprotein as a Novel Surgical-Site Wound Dressing: A Prospective, Randomized, Single-Blinded, Superiority Clinical Trial. Aesthet Surg J Open Forum. 2023 Oct 20;5:ojad071. doi: 10.1093/asjof/ojad071. eCollection 2023.
PubMed 37899912Custis T, Armstrong AW, King TH, Sharon VR, Eisen DB. Effect of Adhesive Strips and Dermal Sutures vs Dermal Sutures Only on Wound Closure: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):862-7. doi: 10.1001/jamadermatol.2015.0174.
PubMed 25875131Takayama S, Yamamoto T, Tsuchiya C, Noguchi H, Sato J, Ishii Y. Comparing Steri-Strip and surgical staple wound closures after primary total knee arthroplasties. Eur J Orthop Surg Traumatol. 2017 Jan;27(1):113-118. doi: 10.1007/s00590-016-1848-x. Epub 2016 Sep 6.
PubMed 27600333Johansen JD, Aalto-Korte K, Agner T, Andersen KE, Bircher A, Bruze M, Cannavo A, Gimenez-Arnau A, Goncalo M, Goossens A, John SM, Liden C, Lindberg M, Mahler V, Matura M, Rustemeyer T, Serup J, Spiewak R, Thyssen JP, Vigan M, White IR, Wilkinson M, Uter W. European Society of Contact Dermatitis guideline for diagnostic patch testing - recommendations on best practice. Contact Dermatitis. 2015 Oct;73(4):195-221. doi: 10.1111/cod.12432. Epub 2015 Jul 14.
PubMed 26179009Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.
PubMed 27806156