ID

31954

Description

Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold; ODM derived from: https://clinicaltrials.gov/show/NCT02059252 Collaborating Parties: Welsh Centre for Burns and Plastic Surgery, Swansea, UK Queen Victoria Hospital NHS Foundation Trust

Link

https://clinicaltrials.gov/show/NCT02059252

Keywords

Versions (2)
  1. 10/7/18 10/7/18 -
  2. 10/9/18 10/9/18 - Sarah Riepenhausen
Copyright Holder

Smart Matrix Limited

Uploaded on

October 9, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT02059252

English

Eligibility Basal Cell Carcinoma NCT02059252

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, at least 18 years of age
Description

Gender and Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
suspected or histologically proven bcc or scc
Description

BCC or SCC

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0332147
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0449575
UMLS CUI [3,1]
C0007137
UMLS CUI [3,2]
C0332147
UMLS CUI [4,1]
C0007137
UMLS CUI [4,2]
C0449575
suspected or histologically proven bcc or scc ≥1cm ≤3cm in diameter on either leg
Description

BCC or SCC on either leg

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C1140621
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C1140621
UMLS CUI [3]
C0449453
UMLS CUI [4,1]
C0450429
UMLS CUI [4,2]
C2986546
expected defect following surgery ≥3cm, ≤6cm in diameter
Description

Expected defect following surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0332803
UMLS CUI [1,2]
C0456389
patient or authorised representative able to comprehend and sign the informed consent prior to enrolment in the study
Description

Patient or authorised representative provide Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C2739015
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
aged <18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0001779
pregnant or lactating females
Description

Pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
skin lesion >4cm in diameter or size that will result in post-surgical defect >6cm in diameter
Description

Skin lesion and post-surgical defect

Data type

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0332803
UMLS CUI [2,2]
C0456389
lesion located over joint, i.e. ankle or knee
Description

Lesion locatet over joint

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0022417
patient who are smokers
Description

Smoker

Data type

boolean

Alias
UMLS CUI [1]
C1519386
diabetic patients
Description

Diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
patients diagnosed with peripheral vascular disease or venous stasis
Description

Peripheral vascular disease or venous stasis

Data type

boolean

Alias
UMLS CUI [1]
C0085096
UMLS CUI [2]
C0745949
patients receiving regular systemic steroids
Description

Receiving systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
patients who are immuno-compromised (either acquired or congenital)
Description

Immuno-compromised patients

Data type

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0439661
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C1744681
patients with a known coagulopathy (either acquired or congenital) but not including patients on aspirin or other anti-platelet therapy
Description

Known coagulopathy except ASS or anti-platelet therapy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0085826
patients who have received radiotherapy treatment to the area about to be treated with smart matrix
Description

History of radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0005902
UMLS CUI [1,4]
C1521840
concurrent participation in another experimental intervention or drug study
Description

Concurrent participation in another study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
unwilling or unable to provide informed consent
Description

Unwilling or unable to provide informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Basal Cell Carcinoma NCT02059252

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender and Age
Item
male or female, at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
BCC or SCC
Item
suspected or histologically proven bcc or scc
boolean
C0007117 (UMLS CUI [1,1])
C0332147 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C0449575 (UMLS CUI [2,2])
C0007137 (UMLS CUI [3,1])
C0332147 (UMLS CUI [3,2])
C0007137 (UMLS CUI [4,1])
C0449575 (UMLS CUI [4,2])
BCC or SCC on either leg
Item
suspected or histologically proven bcc or scc ≥1cm ≤3cm in diameter on either leg
boolean
C0007117 (UMLS CUI [1,1])
C1140621 (UMLS CUI [1,2])
C0007137 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C0449453 (UMLS CUI [3])
C0450429 (UMLS CUI [4,1])
C2986546 (UMLS CUI [4,2])
Expected defect following surgery
Item
expected defect following surgery ≥3cm, ≤6cm in diameter
boolean
C0332803 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Patient or authorised representative provide Informed consent
Item
patient or authorised representative able to comprehend and sign the informed consent prior to enrolment in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C2739015 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
aged <18 years of age
boolean
C0008059 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Pregnant or lactating
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Skin lesion and post-surgical defect
Item
skin lesion >4cm in diameter or size that will result in post-surgical defect >6cm in diameter
boolean
C0037284 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0332803 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Lesion locatet over joint
Item
lesion located over joint, i.e. ankle or knee
boolean
C0221198 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
Smoker
Item
patient who are smokers
boolean
C1519386 (UMLS CUI [1])
Diabetes
Item
diabetic patients
boolean
C0011849 (UMLS CUI [1])
Peripheral vascular disease or venous stasis
Item
patients diagnosed with peripheral vascular disease or venous stasis
boolean
C0085096 (UMLS CUI [1])
C0745949 (UMLS CUI [2])
Receiving systemic steroids
Item
patients receiving regular systemic steroids
boolean
C2825233 (UMLS CUI [1])
Immuno-compromised patients
Item
patients who are immuno-compromised (either acquired or congenital)
boolean
C4048329 (UMLS CUI [1,1])
C0439661 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C1744681 (UMLS CUI [2,2])
Known coagulopathy except ASS or anti-platelet therapy
Item
patients with a known coagulopathy (either acquired or congenital) but not including patients on aspirin or other anti-platelet therapy
boolean
C0005779 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0085826 (UMLS CUI [3,2])
History of radiotherapy
Item
patients who have received radiotherapy treatment to the area about to be treated with smart matrix
boolean
C1522449 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0005902 (UMLS CUI [1,3])
C1521840 (UMLS CUI [1,4])
Concurrent participation in another study
Item
concurrent participation in another experimental intervention or drug study
boolean
C2348568 (UMLS CUI [1])
Unwilling or unable to provide informed consent
Item
unwilling or unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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