Study and compare the effect of Intralesional Radiofrequency and carbon dioxide Laser in Keloid and hypertrophic Scar

Recruiting

Conditions: Hypertrophic scar,

Registration Number: CTRI/2019/08/020883

Lead Sponsor: Department of dermatology Government Medical College Bhavnagar

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients with Keloid and hypertrophic scar Progressive or Stationary lesion Size <10 cm in any dimension No previous treatment in last 6 weeks.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Excellent response (90 %- almost complete flattening)	28 weeks
Good response (71-90 % Significant flattening)	28 weeks
Moderate response (51-70 % Adequate flattening)	28 weeks
Poor response (â‰¤50 % Inadequate flattening)	28 weeks

Secondary Outcome Measures

Name	Time	Method
Size	Height

Trial Locations

Locations (1): Sir T. Hospital and Government medical college, Bhavnagar
🇮🇳
Bhavnagar, GUJARAT, India
Sir T. Hospital and Government medical college, Bhavnagar
🇮🇳Bhavnagar, GUJARAT, India
Dr Nancy Raiyani
Principal investigator
9925025024
nancy.raiyani@gmail.com