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Trial registered on ANZCTR


Registration number
ACTRN12614000368639
Ethics application status
Approved
Date submitted
16/01/2014
Date registered
7/04/2014
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
Comparison of efficacy of excision with intralesional 5- fluorouracil and excision with radiotherapy in the treatment of ear keloids: randomised control trial
Secondary ID [1] 283919 0
Nil
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ear Keloids 290918 0
Condition category
Condition code
Skin 291272 291272 0 0
Other skin conditions
Ear 291273 291273 0 0
Other ear disorders
Surgery 291413 291413 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In group B (interventional group) patients will undergo excision of the keloid under local anesthesia [2% lignocaine + 1:100,000 Adrenaline] using 3cc syringe followed by Intralesional 5-Fluorouracil [5-FU] injection with 1cc syringe and 27G needle average volumes to be 0.2 to 0.4 ml/cm2 in divided doses between the excision margin and the wound bed. With maximum dose not exceeding 150mg (50mg/ml injection). All patients will be seen at 7th day postoperatively for suture removal and then again at approximately 1 month and 2 months postoperatively for 5-FU injection. The dose of subsequent injection will be same. If there is no evidence of recurrence at the 2-month postoperative visit, the injections will be stopped. For those that showed hypertrophy either at completion of the second injection or on subsequent return, the injections will be continued at regular intervals in an attempt to arrest the inflammatory process. The injections will be stopped when the hypertrophy will worsen to the point of keloid formation or the hypertrophic process will subside with eventual flattening and resolution of the scar.
Intervention code [1] 288602 0
Treatment: Surgery
Intervention code [2] 288603 0
Treatment: Drugs
Intervention code [3] 288604 0
Treatment: Other
Comparator / control treatment
Group A, patients will have excision similar to group A, followed by radiotherapy of total 10 Gy (2 fractions in two days) starting within 24 hours of excision. The target volume will be limited to the scar plus a 0.5-cm margin on both sides of suture lines. Ear lobe will be tapered away from the face and a direct anteroposterior field (with a small cone) will be used.
Control group
Active

Outcomes
Primary outcome [1] 291276 0
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.
Timepoint [1] 291276 0
at 4 weeks and then every six months till 1 year after the end of treatment
Secondary outcome [1] 306408 0
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.
Timepoint [1] 306408 0
at 4 weeks and then every six months till 1 year after the end of treatment

Eligibility
Key inclusion criteria
* Age above 12 years/either sex
* Ear keloid more than 10mm in size measured clinically
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a random number table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size of 120 cases; 60 cases in each group is calculated with 80% power of test, 5% level of significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2014
Actual
17/05/2014
Date of last participant enrolment
Anticipated
Actual
24/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5752 0
Pakistan
State/province [1] 5752 0
Punjab

Funding & Sponsors
Funding source category [1] 288563 0
Self funded/Unfunded
Name [1] 288563 0
Country [1] 288563 0
Primary sponsor type
Individual
Name
Farrukh Aslam Khalid
Address
Department of Plastic Surgery, Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 287277 0
Individual
Name [1] 287277 0
Usman Khalid
Address [1] 287277 0
Department of Plastic Surgery, Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country [1] 287277 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290426 0
Ethical Review Board, Allama Iqbal Medical College, Jinnah Hospital
Ethics committee address [1] 290426 0
Prof. Arif M. Siddiqui
Chairman Ethical Review Board,
Medica Unit 3
Allama Iqbal Medical College, Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Ethics committee country [1] 290426 0
Pakistan
Date submitted for ethics approval [1] 290426 0
20/01/2014
Approval date [1] 290426 0
12/05/2014
Ethics approval number [1] 290426 0
19-04/ERB/19th

Summary
Brief summary
After approval from Ethical committee of our hospital, 120 patients presenting in the Department of Plastic Surgery through out patient department of Jinnah hospital, fulfilling the selection criteria will be included in the study. An informed consent will be obtained from them. Patients will be divided randomly in two groups by the help of random number table; Group A will be the patients of post excision radiotherapy and group B will be the patients post excision 5-FU.
All the patients will be photographed and baseline assessment will be done before initiation of treatment by filling the proforma attached. All patients will undergo excision of the keloid under local anesthesia [2% lignocaine with 1:100,000 Adrenaline]. In group A, all patients will receive radiotherapy of total 10 Gy (2 fractions in two days) starting within 24 hours of excision. The target volume will be limited to the scar plus a 0.5-cm margin on both sides of suture lines. Ear lobe will be tapered away from the face and a direct anteroposterior field (with a small cone) will be used. In group B, excision followed by Intralesional 5-Fluorouracil [5-FU] injection in the dose of 50-150 mg divided between the excision margin and the wound bed. 5-FU will be given at two weekly interval. After giving local anesthesia [2% lignocaine +1:100,000 Adrenaline] using a 3cc syringe, 5-FU will be injected in the body of scar by using a 1cc syringe with premounted 27G needle, until slight blanching will be clinically visible.
Assessment of patient will be done at 4, 8 weeks of treatment and 4 weeks after completion of treatment and then 6 monthly till 1 year for recurrance and mean scar reduction by the researcher.
Trial website
Trial related presentations / publications
Send for ISBI 2016, Miami
Public notes

Contacts
Principal investigator
Name 45618 0
Dr Farrukh Aslam Khalid
Address 45618 0
Department of Plastic Surgery Allama Iqbal Medical College/ Jinnah Hospital Allama Shabbir Ahmed Usmani Road, Lahore 54550
Country 45618 0
Pakistan
Phone 45618 0
+923009671600
Fax 45618 0
Email 45618 0
[email protected]
Contact person for public queries
Name 45619 0
Usman Khalid
Address 45619 0
Department of Plastic Surgery Allama Iqbal Medical College/ Jinnah Hospital Allama Shabbir Ahmed Usmani Road, Lahore 54550
Country 45619 0
Pakistan
Phone 45619 0
+923224006089
Fax 45619 0
Email 45619 0
[email protected]
Contact person for scientific queries
Name 45620 0
Usman Khalid
Address 45620 0
Department of Plastic Surgery Allama Iqbal Medical College/ Jinnah Hospital Allama Shabbir Ahmed Usmani Road, Lahore 54550
Country 45620 0
Pakistan
Phone 45620 0
+923224006089
Fax 45620 0
Email 45620 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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