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

27 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Turchia (Türkiye)
    • Kartal
      • Istanbul, Kartal, Turchia (Türkiye), 34865
        • Kartal Dr Lutfi Kırdar City Hospital
        • Contatto:
        • Investigatore principale:
          • Burak Kersin, md
        • Sub-investigatore:
          • Zeynep Erdoğan Çetin, md
        • Sub-investigatore:
          • Koray Islek, md

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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)
Dispositivo: 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.
Altri nomi:
  • PLINEST One
  • Polynucleotides Highly Purified Technology
Comparatore placebo: 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
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient and Observer Scar Assessment Scale (POSAS) Score at 24 Weeks
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient and Observer Scar Assessment Scale (POSAS) Scores at 4 and 12 Weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

7 novembre 2026

Completamento primario (Stimato)

1 novembre 2027

Completamento dello studio (Stimato)

1 novembre 2027

Date di iscrizione allo studio

Primo inviato

24 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2026

Primo Inserito (Effettivo)

28 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KDLK-KBB-PNHPT-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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