Postoperative Surgical ScarNCT07791953
Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy
A study testing Polynucleotide (PN-HPT) and Sterile 0.9% Sodium Chloride in people with Postoperative Surgical Scar and Scar, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Postoperative Surgical Scar, Scar, Scar Formation
- What is being tested?
- Polynucleotide (PN-HPT) and Sterile 0.9% Sodium Chloride
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2026to 1 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kartal Dr Lutfi Kırdar City Hospital
Istanbul, Kartal, 34865
koray ıslek, md, +905380457016, islekkoray@gmail.com
Burak Kersin, md
About this study
Official title: Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy and Parathyroidectomy
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Postoperative Surgical Scar, Scar, Scar Formation, Neck Scar
- Being tested
- Polynucleotide (PN-HPT), Sterile 0.9% Sodium Chloride
- Keywords
- Polynucleotide, PN-HPT, PLINEST One, Postoperative Surgical Scar, Scar Quality, Wound Healing, Patient and Observer Scar Assessment Scale (POSAS), Vancouver Scar Scale, Thyroidectomy, Parathyroidectomy
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polynucleotide (PN-HPT)Device
Also called PLINEST One, Polynucleotides Highly Purified Technology
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Sterile 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks after surgery
Secondary outcomes (3)
Patient and Observer Scar Assessment Scale (POSAS) Scores at 4 and 12 Weeks
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.
Measured: 4 and 12 weeks after surgery
Vancouver Scar Scale Score
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.
Measured: 4, 12, and 24 weeks after surgery
Scar Width
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.
Measured: postoperative day 1 and 4-12- 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start20 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Surgical ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Koray Islek, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791953
- Sponsor's protocol ID
- KDLK-KBB-PNHPT-2026-01
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of privacy and confidentiality considerations and institutional policies regarding the protection of participant data.
Publications
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.
PubMed 35531796Araco 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.
PubMed 39812340Kim 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.
PubMed 29574803