Clinical trial NCT06957444: Rate of Allergic Contact Dermatitis and Cosmetic Outcomes
Official title: Rate of Allergic Contact Dermatitis and Cosmetic Outcomes for Three Wound Closure Techniques in Joint Arthroplasty Patients: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergic Contact Dermatitis
Osteoarthritis, Hip
Osteoarthritis, Knee
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of allergic contact dermatitis (4 Days Post Op)
timeFrame: 4 Days Post-Op
measure: Rate of allergic contact dermatitis (2 Weeks Post Op)
timeFrame: 2 Weeks Post-Op
measure: Rate of allergic contact dermatitis (6 Weeks Post Op)
timeFrame: 6 Weeks Post-Op
measure: Rate of allergic contact dermatitis (3 Months Post Op)
timeFrame: 3 Months Post-Op
Secondary outcomes:
measure: Difference in Cosmetic Outcome (4 Days Post-Op)
timeFrame: 4 Days Post-Op
measure: Difference in Cosmetic Outcome (2 Weeks Post-Op)
timeFrame: 2 Weeks Post-Op
measure: Difference in Cosmetic Outcome (6 Weeks Post-Op)
timeFrame: 6 Weeks Post-Op
measure: Difference in Cosmetic Outcome (3 Months Post-Op)
timeFrame: 3 Months Post-Op
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University Department of Orthopaedics
name: Benjamin Frye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.