Neck Scar, Postoperative Surgical Scar, Scar, Scar Formation
Conditions
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
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.
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.
Interventions
DEVICEPolynucleotide (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 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.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) Scores at 4 and 12 Weeks | 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. |
| Vancouver Scar Scale Score | 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. |
| Scar Width | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed