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临床试验/NCT06965088
NCT06965088进行中(未招募)2 期

Comparison of Recurrence Rate of Keloid After Excision Between Intra-operative Steroid Injection and Steroid With Platelet-rich Plasma Injection Combination Therapy

Ramathibodi Hospital1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2025年4月28日最近更新:
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
212
试验地点
1
主要终点
Recurrence rate of keloid

研究概览

简要总结

Keloid scars are benign skin lesions characterized by excessive collagen deposition, and their treatment remains challenging due to a high recurrence rate even after surgical excision. Combination therapies have been shown to be more effective than monotherapy. A common approach for treating recurrent keloids is surgical excision followed by intralesional corticosteroid injection; however, recurrence rates remain substantial. This study was conducted to evaluate the recurrence rate of keloid scars following surgical excision combined with intralesional corticosteroid and platelet-rich plasma (PRP) injection, compared to corticosteroid injection alone administered intraoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Aged 18 years or older
  • Having keloid scars less than 10 centimeters in length
  • Undergoing complete keloid excision (extralesional excision)
  • Undergoing surgery under local anesthesia

排除标准

  • Patients currently receiving immunosuppressive drugs or systemic steroids
  • Patients with chronic diseases under active treatment, such as tuberculosis
  • Pregnant or breastfeeding women
  • Patients likely to have poor treatment adherence, such as those with cancer, epilepsy, or psychiatric disorders
  • Patients with vascular diseases or hematologic/coagulation abnormalities

研究组 & 干预措施

Intra-operative corticosteroid injection

Active Comparator

Intra-operative corticosteroid injection alone was administered around the surgical wound using triamcinolone acetonide (40 mg/ml). The injection was performed into the intradermal layer using a 30G needle, immediately after keloid excision and wound closure. The medication was injected along the wound edges following the suture line, at a dosage of 0.1 ml per 1 centimeter of wound length.

干预措施: Intra-operative corticosteroid injection (Drug)

Combined Intra-operative platelet-rich plasma with corticosteroid injection

Experimental

Combined Intra-operative platelet-rich plasma with corticosteroid injection was administered around the surgical wound. Each patient had 10 ml of blood collected into a RegenKit A-PRP tube. The blood-filled tube was then placed into a RegenLab PRP centrifuge and spun for approximately 5 minutes to obtain platelet-rich plasma (PRP), yielding around 5 ml of injectable PRP. Once prepared, the PRP was stored in the collection tube and used within 4 hours from the time of blood draw to the time of injection. After the keloid excision and wound closure were completed, the PRP was aseptically aspirated from the tube using a sterile needle and injected into the intradermal layer along the wound edges using a 30G needle. The injection was performed in a sterile manner, with a dosage of 0.5 ml of PRP per 1 centimeter of wound length. For corticosteroid administration, triamcinolone acetonide (40 mg/ml) was used. The medication was injected into the intradermal layer using a 30G needle along the

干预措施: Combined Intra-operative platelet-rich plasma with corticosteroid injection (Biological)

结局指标

主要结局

Recurrence rate of keloid

时间窗: Within 12 months after end of the intervention

Vancouver scar scale

次要结局

  • Itching at scar(Within 12 months after end of the intervention)
  • Pain at scar(Within 12 months after end of the intervention)
  • Skin atrophy(Within 12 months after end of the intervention)
  • Skin telangiectasia(Within 12 months after end of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chanokchon Kongkergkiat

Chanokchon Kongkergkiat, M.D.

Ramathibodi Hospital

研究点 (1)

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