Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

NCT06957444 | Enrolling By Invitation DMC

• 1 other identifier: 2503134113
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Contact Dermatitis; Osteoarthritis, Hip; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  3 Months Post-Op

Secondary Outcomes (4)

• Difference in Cosmetic Outcome (4 Days Post-Op)

  4 Days Post-Op

• Difference in Cosmetic Outcome (2 Weeks Post-Op)

  2 Weeks Post-Op

• Difference in Cosmetic Outcome (6 Weeks Post-Op)

  6 Weeks Post-Op

• Difference in Cosmetic Outcome (3 Months Post-Op)

  3 Months Post-Op

Study Arms (3)

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

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

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

Procedure: Suture Strip Plus

Interventions

Sylke Adhesive Dressing PROCEDURE

Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.

Sylke Adhesive Dressing

Exofin Skin Glue PROCEDURE

2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.

Exofin Skin Glue

Suture Strip Plus PROCEDURE

Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.

Suture Strip Plus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

Related Publications (12)

• 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.

  PMID: 34605793 BACKGROUND

• 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.

  PMID: 38654960 BACKGROUND

• 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.

  PMID: 32882052 BACKGROUND

• 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.

  PMID: 38386590 BACKGROUND

• 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.

  PMID: 27826010 BACKGROUND

• 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.

  PMID: 40046929 BACKGROUND

• 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.

  PMID: 38330504 BACKGROUND

• 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.

  PMID: 37899912 BACKGROUND

• 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.

  PMID: 25875131 BACKGROUND

• 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.

  PMID: 27600333 BACKGROUND

• 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.

  PMID: 26179009 BACKGROUND

• 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.

  PMID: 27806156 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Allergic Contact; Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Benjamin Frye, MD

  West Virginia University Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Fellowship Director Adult Reconstruction

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)