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Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy and Parathyroidectomy

27 augustus 2026 bijgewerkt door: Koray Islek, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a prospective, single-center, two-arm, parallel-group, randomized, placebo-controlled clinical trial designed to evaluate the effect of a single intraoperative polynucleotide injection on postoperative scar quality after open thyroidectomy, thyroid lobectomy, or parathyroidectomy.

A total of 80 participants will be randomly assigned in a 1:1 ratio to either the polynucleotide group or the placebo group using a computer-generated randomization list. Participants assigned to the intervention group will receive PLINEST One PN-HPT (Polynucleotides Highly Purified Technology). Participants assigned to the control group will receive sterile 0.9% sodium chloride solution.

The study solution will be administered immediately after completion of skin closure and before the final surgical dressing is applied. In both groups, the total injection volume will be calculated according to incision length at 0.5 mL per centimeter. The solution will be distributed evenly along the entire incision line using a 34-gauge needle and will be injected intradermally or into the superficial subdermal plane. The placebo will be administered using the same volume, anatomical plane, needle size, syringe type, and injection pattern as the active treatment.

Study solutions will be prepared in coded syringes by a member of the research team who is not involved in postoperative scar assessment. Participants, postoperative scar assessors, and the researcher performing the statistical analysis will be blinded to treatment allocation. If differences in injection characteristics make treatment allocation apparent to the person administering the injection, that individual will not participate in postoperative assessments or data analysis.

Surgical skin closure and postoperative wound care will be standardized between the two groups to reduce factors that could affect scar formation.

Participants will undergo preoperative assessment and postoperative evaluations on day 1, days 7 to 10, and at weeks 4, 12, and 24. An optional long-term assessment may also be performed at week 52. Standardized digital photographs will be obtained using consistent lighting, camera distance, participant position, and background whenever possible.

Scar quality will be evaluated over time using the Patient and Observer Scar Assessment Scale (POSAS), the Vancouver Scar Scale, clinical scar measurements, standardized photographs, scar-related symptoms, participant satisfaction, wound complications, and local or systemic reactions related to the injection. The primary assessment time point is postoperative week 24. Changes over time and differences between treatment groups will be evaluated using appropriate repeated-measures statistical methods.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
    • Kartal
      • Istanbul, Kartal, Turkije (Türkiye), 34865
        • Kartal Dr Lutfi Kırdar City Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Burak Kersin, md
        • Onderonderzoeker:
          • Zeynep Erdoğan Çetin, md
        • Onderonderzoeker:
          • Koray Islek, md

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Adults aged 40 to 60 years.
  • Scheduled to undergo open thyroidectomy, thyroid lobectomy, or parathyroidectomy through a standard anterior cervical (Kocher) incision.
  • Undergoing anterior neck surgery for the first time.
  • Able to provide written informed consent.
  • Willing to attend the planned postoperative follow-up visits.
  • Able and willing to comply with the study procedures.

Exclusion Criteria:

  • Younger than 40 years or older than 60 years.
  • Previous anterior neck surgery.
  • Pre-existing scar in the planned incision area.
  • History of hypertrophic scar or keloid formation.
  • Previous radiotherapy to the neck.
  • Active dermatologic disease involving the anterior neck.
  • Active local or systemic infection.
  • Uncontrolled diabetes mellitus.
  • Current use of systemic corticosteroids or immunosuppressive medications.
  • Pregnancy or breastfeeding.
  • Known hypersensitivity to fish, salmonid-derived products, polynucleotides, or any component of PLINEST One.
  • Coagulation disorder or clinically significant bleeding tendency.
  • Use of anticoagulant therapy that constitutes a contraindication to intradermal injection.
  • Any contraindication to mesotherapy, intradermal injection, or injectable biostimulant procedures.
  • Inability or unwillingness to comply with the planned follow-up assessments.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PN-HPT Group

Participants will receive a single intraoperative injection of PLINEST One PN-HPT along the surgical incision immediately after skin closure.

Intervention:

PLINEST One PN-HPT (CE 0373-Marked Class III Medical Device Containing Highly Purified Polynucleotides)
Apparaat: 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.
Andere namen:
  • PLINEST One
  • Polynucleotides Highly Purified Technology
Placebo-vergelijker: Placebo Group

Participants will receive a single intraoperative injection of sterile 0.9% sodium chloride along the surgical incision immediately after skin closure.

Intervention:

Sterile 0.9% Sodium Chloride
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient and Observer Scar Assessment Scale (POSAS) Score at 24 Weeks
Tijdsspanne: 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.
24 weeks after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient and Observer Scar Assessment Scale (POSAS) Scores at 4 and 12 Weeks
Tijdsspanne: 4 and 12 weeks after surgery
Postoperative scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS v3). Total and subscale scores will be compared between the PN-HPT and placebo groups. Patient and Observer Scar Assessment Scale 3.0 (POSAS 3.0) - Observer Scale, with scores ranging from 6 to 60; higher scores indicate worse scar quality.
4 and 12 weeks after surgery
Vancouver Scar Scale Score
Tijdsspanne: 4, 12, and 24 weeks after surgery
Scar quality will be assessed using the Vancouver Scar Scale, including its clinical scar characteristics. Scar quality will be assessed using the Vancouver Scar Scale (VSS), with total scores ranging from 0 to 13; higher scores indicate worse scar quality.
4, 12, and 24 weeks after surgery
Scar Width
Tijdsspanne: postoperative day 1 and 4-12- 24 weeks after surgery
Scar length will be measured in millimeters at the time of surgery and at 4, 12, and 24 weeks postoperatively. The change in scar length from the time of surgery will be assessed at each follow-up visit.
postoperative day 1 and 4-12- 24 weeks after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

7 november 2026

Primaire voltooiing (Geschat)

1 november 2027

Studie voltooiing (Geschat)

1 november 2027

Studieregistratiedata

Eerst ingediend

24 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 augustus 2026

Eerst geplaatst (Werkelijk)

28 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KDLK-KBB-PNHPT-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because of privacy and confidentiality considerations and institutional policies regarding the protection of participant data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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