A comparative clinical trial to study the effects of surgery combined with radiation therapy and surgery combined with 5- Fluorouracil in patients with ear Keloids

Phase 4

Completed

• Conditions: Ear Keloids; Skin - Other skin conditions; Ear - Other ear disorders; Surgery - Other surgery

• Registration Number: ACTRN12614000368639
• Lead Sponsor: Farrukh Aslam Khalid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

* Age above 12 years/either sex
* Ear keloid more than 10mm in size measured clinically

Exclusion Criteria

* History of treatment taken in last 6 months
* History of chronic renal failure or serum creatinine > 1.2mg/dl.
* Abnormalities in liver function tests (ALT > 35 IU) and blood counts (WBC < 4 or > 11 thousand cells) on laboratory investigations.
* Pregnant/lactating women or planning pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Comparison of efficacy of excision with intralesional 5- FU and excision with radiotherapy in the treatment of ear keloids for recurrence by clinical examination and will be presented as frequency and percentage. Chi square will be used to compare both groups.[at 4 weeks and then every six months till 1 year after the end of treatment]

Secondary Outcome Measures

Name	Time	Method
To Comparison of efficacy of excision with intralesional 5- FU and excision with radiotherapy in the treatment of ear keloids for mean reduction in scar height by caliper and will be presented as percentage. Chi square will be used to compare both groups.[at 4 weeks and then every six months till 1 year after the end of treatment]