Tokyo, April 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061193) titled 'Ultra-early steroid tape intervention for preventing hypertrophic scars after TKA: a randomized controlled trial' on April 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Yoshinori Mikashima

Condition: Condition - Osteoarthritis of the knee Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to determine whether ultra-early initiation of steroid tape therapy at 1 month after total knee arthroplasty is more effective in reducing hypertrophic scar thickness and improving pruritus NRS scores compared with delayed initiation at 3 months postoperatively. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Delayed intervention group (Control) Delayed initiation of steroid tape therapy starting at 3 months after total knee arthroplasty. Steroid tape is applied from postoperative month 3 as part of standard scar management, and scar thickness and pruritus are assessed over time. Interventions/Control_2 - Ultra-early intervention group (Intervention) Ultra-early initiation of steroid tape therapy starting at 1 month after total knee arthroplasty. Steroid tape is applied from postoperative month 1, and scar thickness and pruritus NRS scores are assessed over time.

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - Key inclusion criteria 1. Patients undergoing primary total knee arthroplasty for knee osteoarthritis. 2. Patients with a fully epithelialized incision and no signs of infection at 1 month postoperatively. 3. Patients who wish to receive steroid tape therapy and provide written informed consent. 4. Patients who are able to complete follow-up assessments up to 6 months after surgery. Key exclusion criteria - Exclusion criteria - Patients who show any signs of wound infection (e.g., erythema, discharge, warmth) at 1 month postoperatively. - Patients whose incision is not fully epithelialized and for whom steroid tape application is not considered safe. - Patients with known allergies to topical steroids or adhesive materials used in the tape. - Patients receiving immunosuppressive therapy or systemic corticosteroid treatment. - Patients with severe dermatologic conditions that may affect wound healing. - Patients undergoing revision TKA or those with infectious arthritis or other non-primary TKA indications. - Patients who are unlikely to complete follow-up assessments up to 6 months after surgery. - Patients who are unable or unwilling to provide written informed consent. Target Size - 110

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 08 Day Date of IRB - 2026 Year 04 Month 08 Day Anticipated trial start date - 2026 Year 04 Month 08 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070026

Disclaimer: Curated by HT Syndication.