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临床试验/NCT06580691
NCT06580691已完成不适用

Autologous Plasma Gel Injection Versus Polydioxanone Cog Threads Insertion for the Treatment of Atrophic Post-acne Scars: a Split-face

Sameh Sarsik1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Clinical improvement

研究概览

简要总结

Both male and female patients, with atrophic acne scars

All patients underwent one session of subcision before receiving:

A: cog PDO threads on one side of the face (one session). B: plasma gel on the other side (one session). Primary outcomes: clinical improvements reported by physicians. Secondary out come: satisfaction levels of patients.

详细描述

The treatment area was prepared by anesthetizing the acne-scarred region with a 2% lidocaine injection mixed with 1/1000 adrenaline, administered at each entry point after sterilizing the area with povidone-iodine solution. Subcision was performed using an 18-G cannula needle inserted parallel to the skin surface. The skin was stretched while the needle was maneuvered along the scar margins on both sides of the face, creating a tunnel and releasing the scars from their bases. The procedure's endpoint was marked by a partial to complete loss of resistance in the treated area.

After subcision, patients underwent the following treatments:

Plasma Gel Therapy: One half of the face was assigned to the plasma gel therapy group. Plasma gel was prepared in two steps:

Platelet Poor Plasma (PPP) Preparation: Ten milliliters of venous blood were drawn from each patient and collected in sterile, anticoagulant-equipped vacuum tubes. The blood was centrifuged at 72 g for 15 minutes at room temperature, then the plasma layer was centrifuged again for 5 minutes at 1006 g to yield 6.5 ml of PPP and 0.5 ml of platelet-rich plasma (PRP).

Gel Formation: The PPP syringes were placed in a hot water bath (60-100°C) for 1 minute, then in a cold bath (8-0°C) for 1 minute to turn the plasma into a viscous gel. The gel was injected into the scarred areas immediately after subcision.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over 18 years old, with atrophic acne scars on both sides of their faces of any severity.

排除标准

  • •patients with keloidal tendencies or bleeding disorders.
  • •Participants with a history of recent isotretinoin use within 3 months
  • •Patients who underwent any procedure for treatment of acne scars during the last 6 months.

研究组 & 干预措施

Subcision plus Plasma gel

Active Comparator

The gel was injected into the scarred areas immediately after subcision.

干预措施: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads (Procedure)

Subcision plus Cog PDO threads

Active Comparator

Cog PDO threads were inserted using a blunt-tipped cannula in a "Z pattern" within the scarred areas, filling the pockets created by subcision.

干预措施: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads (Procedure)

结局指标

主要结局

Clinical improvement

时间窗: after 3 month of the procedure

The improvement was assessed using the Goodman and Baron scale.

次要结局

  • Patients satisfaction.(3 months from the procedure)
  • Side effects of the procedures.(During 3 months from the procedure)

研究者

发起方
Sameh Sarsik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sameh Sarsik

Lecturer

Tanta University

研究点 (1)

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