Rate of Allergic Contact Dermatitis and Cosmetic Outcomes
NCT ID: NCT06957444
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
600 participants
INTERVENTIONAL
2025-07-21
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sylke Adhesive Dressing
Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
Sylke Adhesive Dressing
Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.
Exofin Skin Glue
Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
Exofin Skin Glue
2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.
Suture Strip Plus
Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty
Suture Strip Plus
Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.
Interventions
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Sylke Adhesive Dressing
Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.
Exofin Skin Glue
2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.
Suture Strip Plus
Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* THA used for treatment of a fracture
* Patients participating in other studies that might have involve medications such as antibiotics
18 Years
80 Years
ALL
No
Sponsors
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West Virginia University
OTHER
Responsible Party
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Benjamin Frye
Associate Professor, Fellowship Director Adult Reconstruction
Principal Investigators
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Benjamin Frye, MD
Role: PRINCIPAL_INVESTIGATOR
West Virginia University Department of Orthopaedics
Locations
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West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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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.
Ali 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.
Ricciardo 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.
Pannu 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.
Kim 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.
Zhang 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.
Rouhani 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.
Rouhani 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.
Custis 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.
Takayama 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.
Johansen 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.
Kantor 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.
Other Identifiers
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2503134113
Identifier Type: -
Identifier Source: org_study_id
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