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Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Nov 7, 2026 to Nov 20, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 3 of 3 entries
    • Study title shortened, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn whether a single polynucleotide injection can improve scar quality after thyroid or parathyroid surgery in adults. It will also assess the safety of the injection. The main questions this study aims to answer are the following: Does a single polynucleotide injection improve scar quality 24 weeks after surgery? Does it improve scar appearance and symptoms such as pain, itching, hardness, or tightness? Are there any side effects or wound problems related to the injection? Researchers will compare PLINEST One PN-HPT, a solution containing polynucleotides, with sterile saline, which does not contain polynucleotides. After the surgical incision is closed, participants will receive one injection along the incision line. Participants will be randomly assigned to receive either PLINEST One PN-HPT or saline. Scar healing and appearance will be checked after surgery. Formal scar assessments will be performed at 4, 12, and 24 weeks. Scar quality will be assessed using patient and researcher scar rating scales, scar measurements, photographs, symptoms, and participant satisfaction.
Trial Details
NCT Number NCT07791953
Lead Sponsor Dr. Lutfi Kirdar Kartal Training and Research Hospital
Conditions
(from sponsor)		 Postoperative Surgical Scar, Scar, Scar Formation, Neck Scar
Related terms Cicatrix
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov