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Study Title and Description

Treatment of basal cell carcinoma with surgical excision and perilesional interferon-α.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Treatment of basal cell carcinoma with surgical excision and perilesional interferon-α.
Author Wettstein R., Erba P., Itin P., Schaefer DJ., Kalbermatten DF.
Country Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital of Basel, Basel, Switzerland. drwette@yahoo.com
Year 2013
Numbers Pubmed ID: 23566745

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Mohs + Ringer's lactate (control group)
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2 Mohs + interferon alpha-2b
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Single center
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Country/Region Switzerland
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Funding Industry supplied materials
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Inclusion criteria diagnosed clinically or by biopsy with primary nodular BCC of the face presenting at the University Hospital Basel between June 2007 and February 2008
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Exclusion criteria patients under steroid medication or immunosuppressive therapy; patients with direct defect closure; if pathological analysis revealed incomplete tumour resection or another BCC sub-type than solid/nodular
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N Enrolled/Randomized/Analyzed 32
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23
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23
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Clinical ...
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Preoperative assessment of clinical size of the tumor ... confocal ...
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question Mohs + Ringer's lactate (control group) Mohs + interferon alpha-2b Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 74.4 78.4
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10.11 9.99
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calculated from ipd calculated from ipd
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2.5 3.1
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1.72 2.51
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calculated from ipd calculated from ipd
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Gender/Racial descent nd nd
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nd nd
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Lesion location 6, 3, 1 5, 1, 2
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46.2, 23.1 ,7.7 50, 10, 20
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nose, cheek, frontal nose, cheek, frontal
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3 2
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23.1 20
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Skin type (Fitzpatrick score) nd
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Number of lesions per patient 10 13
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100 100
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Previous treatments nd
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Immunocompromized status nd
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Number of patients/lesions nd nd
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nd nd
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10 13
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10 13
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0 0
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0 0
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10 13
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10 13
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Lesion extent number of people 13 10
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13 10
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solid/nodular solid/nodular
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence or relapse      Population: All Participants Between-Arm Comparisons
Time Point Measure Mohs + Ringer's lactate (control group) Mohs + interferon alpha-2b Comparison Measure Mohs + Ringer's lactate (control group) vs. Mohs + interferon alpha-2b


1 years

N Analyzed 13 10
Counts 1 0


5 years

N Analyzed 6 9 P-Value ns
Counts 0 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Mohs + Ringer's lactate (control group) Mohs + interferon alpha-2b


1 years

N Analyzed 13 10
Counts 2 2
Outcome: Adverse events: other      Population: All Participants Between-Arm Comparisons
Time Point Measure Mohs + Ringer's lactate (control group) Mohs + interferon alpha-2b Comparison Measure Mohs + Ringer's lactate (control group) vs. Mohs + interferon alpha-2b


1 years

N Analyzed 13 10 P-Value ns
Counts 3 3
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure Mohs + Ringer's lactate (control group) Mohs + interferon alpha-2b


1 weeks

N Analyzed 13 10
Counts 0 1
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Mohs + Ringer's lactate (control group) Mohs + interferon alpha-2b


1 years

N Analyzed 13 10
Counts 1 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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RCT:....Adequate allocation concealment reported No Data
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RCT:....Adequate blinding of PATIENTS reported Yes
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RCT:....Adequate blinding of PROVIDERS reported Yes
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No Data
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No
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ALL.....Selective Reporting (judgement - put directly into notes field). Low
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. Yes
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) No
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field) Low
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
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Quality Rating
No quality rating data was found.