NCT07791953

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 24, 2026

Last Update Submit

August 27, 2026

Conditions

Postoperative Surgical ScarScarScar FormationNeck Scar

Keywords

PolynucleotidePN-HPTPLINEST OnePostoperative Surgical ScarScar QualityWound HealingPatient and Observer Scar Assessment Scale (POSAS)Vancouver Scar ScaleThyroidectomyParathyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Patient and Observer Scar Assessment Scale (POSAS) Score at 24 Weeks

    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

Secondary Outcomes (3)

  • Patient and Observer Scar Assessment Scale (POSAS) Scores at 4 and 12 Weeks

    4 and 12 weeks after surgery

  • Vancouver Scar Scale Score

    4, 12, and 24 weeks after surgery

  • Scar Width

    postoperative day 1 and 4-12- 24 weeks after surgery

Study Arms (2)

PN-HPT Group

EXPERIMENTAL

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)

Device: Polynucleotide (PN-HPT)

Placebo Group

PLACEBO COMPARATOR

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

Other: Sterile 0.9% Sodium Chloride

Interventions

Polynucleotide (PN-HPT)DEVICE

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.

Also known as: PLINEST One, Polynucleotides Highly Purified Technology
PN-HPT Group
Sterile 0.9% Sodium ChlorideOTHER

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.

Placebo Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lutfi Kırdar City Hospital

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

Related Publications (3)

  • Araco A, Araco F, Raichi M. Clinical efficacy and safety of polynucleotides highly purified technology (PN-HPT(R)) and cross-linked hyaluronic acid for moderate to severe nasolabial folds: A prospective, randomized, exploratory study. J Cosmet Dermatol. 2023 Jan;22(1):146-155. doi: 10.1111/jocd.15064. Epub 2022 May 26.

    PMID: 35531796RESULT

  • Araco A, Araco F, Raichi M. An Exploratory Study of PN HPT for Treating Postsurgical Atrophic and Depressed Scars. J Cosmet Dermatol. 2025 Jan;24(1):e16764. doi: 10.1111/jocd.16764.

    PMID: 39812340RESULT

  • Kim JH, Jeong JJ, Lee YI, Lee WJ, Lee C, Chung WY, Nam KH, Lee JH. Preventive effect of polynucleotide on post-thyroidectomy scars: A randomized, double-blinded, controlled trial. Lasers Surg Med. 2018 Mar 25. doi: 10.1002/lsm.22812. Online ahead of print.

    PMID: 29574803RESULT

Related Links

MeSH Terms

Conditions

Cicatrix

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants, care providers, outcome assessors, and the statistician will be blinded to treatment allocation. Study solutions will be prepared in identical coded syringes by an independent research team member who will not participate in participant care, postoperative scar assessments, or data analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups: a single intraoperative PLINEST One PN-HPT injection or placebo with sterile 0.9% sodium chloride.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 28, 2026

Study Start (Estimated)

November 7, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations

TU(1)