CClinicalTrials.gg
Enrolling by invitationNCT06957444Updated May 12, 2026

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

An interventional study of Sylke Adhesive Dressing and Exofin Skin Glue in Allergic Contact Dermatitis, Osteoarthritis, Hip and Osteoarthritis, Knee, sponsored by West Virginia University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by West Virginia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Contact Dermatitis
  • Osteoarthritis, Hip
  • Osteoarthritis, Knee
03

In context

Dermatitis, Allergic Contact

50 studies on the registry are indexed under Dermatitis, Allergic Contact; 11 are open to participants now.

This study's planned enrollment of 600 is above the median of 48 across 38 interventional studies indexed under Dermatitis, Allergic Contact.

Browse Dermatitis, Allergic Contact studies →

Lead sponsor

West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Sylke Adhesive Dressing

    Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty

    Procedure: Sylke Adhesive Dressing

  • Active comparator
    Exofin Skin Glue

    Topical Wound Closure to be applied once the deep wound closure is secured after Total Knee or Total Hip Arthroplasty

    Procedure: Exofin Skin Glue

  • Active comparator
    Suture Strip Plus

    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

  • ProcedureSylke Adhesive Dressing

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

  • ProcedureExofin Skin Glue

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

  • ProcedureSuture Strip Plus

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 Days Post-Op

  2. 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.

    Time frame: 2 Weeks Post-Op

  3. 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.

    Time frame: 6 Weeks Post-Op

  4. 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.

    Time frame: 3 Months Post-Op

Secondary outcomes

  1. 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.

    Time frame: 4 Days Post-Op

  2. 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.

    Time frame: 2 Weeks Post-Op

  3. 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.

    Time frame: 6 Weeks Post-Op

  4. 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.

    Time frame: 3 Months Post-Op

07

Study locations

1 site
  • West Virginia University
    Morgantown, West Virginia 26505, United States
08

References and documents

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 34605793 ↗
  • 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. PubMed 38654960 ↗
  • 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. PubMed 32882052 ↗
  • 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. PubMed 38386590 ↗
  • 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. PubMed 27826010 ↗
  • 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. PubMed 40046929 ↗
  • 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. PubMed 38330504 ↗
  • 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. PubMed 37899912 ↗
  • 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. PubMed 25875131 ↗
  • 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. PubMed 27600333 ↗
  • 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. PubMed 26179009 ↗
  • 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. PubMed 27806156 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06957444
Lead sponsor
West Virginia University
Responsible party
Benjamin Frye (Associate Professor, Fellowship Director Adult Reconstruction, West Virginia University) — Principal investigator
First posted
May 4, 2025
Start date
Oct 13, 2025
Primary completion
May 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
May 12, 2026

Study contacts

Benjamin Frye, MD
principal investigator · West Virginia University Department of Orthopaedics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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