Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

NCT ID: NCT06957444

Last Updated: 2025-07-28

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-21

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Contact Dermatitis Osteoarthritis, Hip Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Sylke Adhesive Dressing

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Exofin Skin Glue

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Suture Strip Plus

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Exofin Skin Glue

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

Intervention Type PROCEDURE

Suture Strip Plus

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Frye

Associate Professor, Fellowship Director Adult Reconstruction

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 34605793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38654960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32882052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38386590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27826010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40046929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38330504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37899912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25875131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27600333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26179009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27806156 (View on PubMed)

Other Identifiers

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2503134113

Identifier Type: -

Identifier Source: org_study_id

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