Efficacy of Early Postoperative ON101 Application for Lower-extremity Fracture Incisions: a Prospective Evaluator-blinded Controlled Study of Scar Quality and Digital-clinical Concordance

NCT07854470 | Completed

• 2 other identifiers: LKaiChengKSVGH22-CT11-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete epithelialization before use. Conversely, ON101 is a topical formulation. The formulation helps to maintain the wound moist environment, and the moist wound environment is conducive for wound healing. This profile suggests potential for earlier intervention. We evaluated whether initiating ON101 during the early postoperative repair phase improves subsequent wound healing and scar maturation. Methods: This prospective, evaluator-blinded, controlled study enrolled 30 adults undergoing open reduction and internal fixation for lower-extremity fractures. Patients received once-daily topical ON101 (n=20) or standard care (n=10), initiated within 3 days postoperatively before complete epithelialization, and continued for 16 weeks. Blinded clinicians assessed scar maturation using the Vancouver Scar Scale (VSS). Standardized photographs were quantitatively analyzed using CIELab color parameters and gray-level co-occurrence matrix (GLCM) texture features.

Conditions

Wound Healing

Keywords

ON101; fracture surgery; wound healing; scar quality; Vancouver Scar Scale; digital photography

Outcome Measures

Primary Outcomes (2)

• Vancouver Scar Scale (VSS)

  assesses pigmentation, vascularity, pliability, and scar height.

  Because reliable assessment of height and pliability required suture removal and sufficient wound stabilization, VSS scoring began at V4 and continued through V8.

• photographed

  Observe changes in the wound

  V2 (Day 0, baseline), V3 (Week 1), V4 (Week 2), V5 (Week 4), V6 (Week 8), V7 (Week 12), and V8 (Week 16)

Study Arms (1)

treatment group

EXPERIMENTAL

once daily for 16 weeks

Drug: ON101

Interventions

ON101 DRUG

starting at Day 0,once daily for 16 weeks.

Also known as: treatment group

treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical suture wounds in patients aged 18-65 years with lower extremity or hip fractures.
• Suture wounds within three days after surgery.
• Those who have signed the informed consent form and must be able to follow the trial process.

You may not qualify if:

• Diabetics.
• Pregnant women or lactating mothers.
• Undergo systemic corticosteroid therapy/radiation therapy/immunosuppressive therapy.
• People who are suspected or known to have allergic reactions to the ingredients of this product, including centella asiatica, hand scented extracts or excipients.
• Infection with human immunodeficiency virus (HIV).
• Based on the subject's medical history, it is determined that the subject has a mental condition (such as suicidal ideation), current or chronic alcohol and drug addiction, which the trial moderator believes may have an impact on the subject's compliance with participating in the trial.

Sponsors & Collaborators

• LIN Kai-Cheng: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Interventions

ON101

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Fracture and Trauma Department, Department of Orthopedics, Kaohsiung Veterans General Hospital

Model Details: This study was designed as a prospective, evaluator-blinded, controlled study to investigate the effects of ON101 cream on post-surgical scarring following open reduction and internal fixation of lower extremity fractures (from hip to ankle). From January 2023 to October 2024, patients were enrolled at a single tertiary-referral medical center, where all surgeries were performed by the same orthopedic surgeon to ensure consistency in surgical technique and postoperative care. Eligible participants were adults aged 18-65 years who had undergone primary wound closure for clean surgical incisions resulting from lower extremity or hip fracture surgeries, with ON101 application within three days postoperatively. All participants provided written informed consent and were required to comply with the study protocol. Exclusion criteria included diabetes mellitus, pregnancy or lactation, ongoing systemic corticosteroid, radiation, or immunosuppressive therapy, known or suspected allergies to th

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: October 2, 2026
• Study Start: September 10, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)