A comparative study of effectiveness of Intralesional Radiofrequency and ultra pulse carbondioxide laser ablation in keloid & hypertrophic scar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Excellent response (90 %- almost complete flattening)
研究概览
简要总结
Keloid and hypertrophic scars are caused by disturbance in normal healing process. Delay in wound healing, infection, foreign material in wound, tension on area, hormonal status, genetic constitution, etc. are few of the factors that affect the formation of keloid and its recurrence.
Available different treatment options:
intralesional steroid,
surgical excision,
cryotherapy,
pressure therapy,
silicone gel sheet application,
radiotherapy,
laser therapy,
botulinum toxin, etc.
But, none of the therapeutic option for the treatment of keloid has been found completely effective and satisfactory. Mostly, combination of treatments is necessary for better outcome.
Surgical excision with modification often tried for good cosmesis and/or symptom relief, but mostly complicated by recurrence of keloid.
radiofrequency heating is used to create targeted coagulation and necrosis that result in reduction of volume in treated area.
In co2 laser, 10,600nm laser light is used for selective photothermolysis of full thickness tissue.
Intralesional injection following the procedure is given for suppression of tissue regrowth.
The procedure will be done under local anesthesia.
Study Methodology:
Keloid or hypertrophic scar will be photographed, measured and assessed with other different scales (VSS, POSAS) and noted on Case Record Form with Consent of the Participant or Guardian (in case of minor) after full explanation of the procedure, side effect, other modalities, outcome and other queries.
The chosen procedure will be repeated every monthly (in needed) followed by intralesional injection for consequently 3 months after reassessment of the lesion. Intralesional injection will be carried out monthly for total duration of 6 months(counting from 1st procedure done)
Side effects:
Pain/ itching at treatment site
Edema/ ulcer/ bullae at treatment site
Post procedure advice:
Do not touch/ press repeatedly and scratch over treatment area
On notice of above side effect, inform your treatment doctor as soon as possible
Avoid direct exposure of wound to sunlight and dust
Complete the given medicines
Be on regular follow up for further treatment
Outcome:
Treatment site may not look completely as normal surrounding skin
One or more treatment at same site may be needed at same site.
Recurrence of keloid may happen at treatment site which depends upon physical nature of the person
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Keloid and hypertrophic scar Progressive or Stationary lesion Size <10 cm in any dimension No previous treatment in last 6 weeks.
排除标准
- •Pedunculated lesion Sensitivity to local anesthetic Pregnant females Infected or secondary changes on surface (e.g. excoriation/ eczema) Person with Pacemaker Person with unstable general condition Patient not willing for consent and follow up Patient in need of alternative treatment during the treatment course.
结局指标
主要结局
Excellent response (90 %- almost complete flattening)
时间窗: 28 weeks
Good response (71-90 % Significant flattening)
时间窗: 28 weeks
Moderate response (51-70 % Adequate flattening)
时间窗: 28 weeks
Poor response (≤50 % Inadequate flattening)
时间窗: 28 weeks
次要结局
- Size(Height)