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临床试验/CTRI/2025/02/080106
CTRI/2025/02/080106尚未招募不适用

Outcome analysis of adjuvant radiotherapy after surgical excision in keloids

All India Institute of Medical Sciences, Raipur1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
1
主要终点
To analyze recurrence of keloid after postoperative radiotherapy

研究概览

简要总结

Keloids are abnormal scars that occur due to an imbalance between an increased synthesis of collagen and extracellular matrix and decreased degradation of these products. When treated inadequately, it leads to excessive scar formation that is a physical and emotional distress. Dysregulation of collagen remodeling leads to excessive scar formation and hence disfiguration. They appear slowly over months and progress beyond the confines of the original wound and do not regress spontaneously. Several treatment modalities like interferons, intralesional steroid injections, cryotherapy, laser therapy, silicone gel sheets have been used in the management of keloids. However a high recurrence rates (>50%) persists with these approaches. Surgical excision alone is ineffective and additional treatment modalities are needed and radiotherapy has been used as part of this combination therapy. Adjuvant post operative radiotherapy aims to prevent local recurrence, by targeting immature fibroblasts resulting in suppression of their proliferation, inhibition of collagen synthesis and thereby reducing the recurrence of keloids. There are not enough studies giving a standard protocol for post-operative radiotherapy. In our study, the patient after surgical excision of keloid will be given low dose radiation of 12Gy in 3 fractions over 3 days, starting within 24 hours of the excision. The patient will be followed-up to assess the recurrence of keloids, wound complications such as infection, dehiscence or erythema, and scar assessment using the Patient and observer scar assessment scale (POSAS) in a 3-monthly interval over a duration of 12 months.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with keloid in any part of the body that are planned for excision followed by primary closure or flap closure where no residual open wound is left after excision.

排除标准

  • Uncontrolled diabetes ii.
  • Uncontrolled hypertension iii.
  • Pregnancy iv.
  • Connective tissue disorder v.
  • Prior radiotherapy to same part vi.
  • Patients in whom after keloid excision the wound is not primarily closed or grafted are excluded as adjuvant radiation cannot be applied over open wound.

结局指标

主要结局

To analyze recurrence of keloid after postoperative radiotherapy

时间窗: Immediate post operative asessment, suture removal at day 14, follow up at 3 months, 6 months, 9 months and 12 months from surgery

次要结局

  • Incidence of complication in post operative patients including wound dehiscence , infection , erythema(Patient and observer evaluation using the Patient and Observer Scar Assessment Scale (POSAS))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Jiten Kumar Mishra

All India Institute of Medical Sciences, Raipur

研究点 (1)

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