Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy and Parathyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS) Score at 24 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Polynucleotide (PN-HPT) (Device)
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
干预措施: Sterile 0.9% Sodium Chloride (Other)
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS) Score at 24 Weeks
时间窗: 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.
次要结局
- 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)
研究者
Koray Islek
Resident Doctor
Dr. Lutfi Kirdar Kartal Training and Research Hospital