Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Polynucleotide (PN-HPT): PLINEST One is a CE 0373-marked Class III medical device containing PN-HPT (Polynucleotides Highly Purified Technology). The formulation contains polynucleotides and does not contain hyaluronic acid, mannitol, local anesthetics, corticosteroids, vitamins, peptides, or other added bioactive ingredients. A single dose will be administered immediately after skin closure and before the final surgical dressing. The solution will be injected intradermally or into the superficial subdermal plane along the entire surgical incision using a 34-gauge needle. The total volume will be calculated as 0.5 mL per centimeter of incision length and distributed evenly along the incision line.

Sterile 0.9% Sodium Chloride: Sterile 0.9% sodium chloride solution will be administered as the placebo comparator. A single dose will be injected immediately after skin closure and before the final surgical dressing. The solution will be injected intradermally or into the superficial subdermal plane along the entire surgical incision using a 34-gauge needle and a 3 mL Luer-lock syringe. The total volume will be calculated as 0.5 mL per centimeter of incision length and distributed evenly along the incision line. The injection volume, anatomical plane, needle size, syringe type, and injection pattern will match those used in the PN-HPT group.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Patient and Observer Scar Assessment Scale (POSAS) Score at 24 Weeks — 24 weeks after surgery
  Postoperative scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS v3). Total and subscale scores from the patient and observer assessments will be compared between the PN-HPT and placebo groups. Patient and Observer Scar Assessment Scale 3.0 (POSAS 3.0) with scores ranging from 6 to 60; higher scores indicate worse scar quality.

Trial sites (1)

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