Comparison of Recurrence Rate of Keloid After Excision Between Intra-operative Steroid Injection and Steroid With Platelet-rich Plasma Injection Combination Therapy
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
- 否
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
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
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
Chanokchon Kongkergkiat
Chanokchon Kongkergkiat, M.D.
Ramathibodi Hospital
