ID

15656

Description

EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds; ODM derived from: https://clinicaltrials.gov/show/NCT02409628

Link

https://clinicaltrials.gov/show/NCT02409628

Keywords

Versions (1)
  1. 6/7/16 6/7/16 -
Uploaded on

June 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-melanoma Skin Cancer NCT02409628

English

Eligibility Non-melanoma Skin Cancer NCT02409628

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
is the patient at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
is the patient male, or is not pregnant or lactating and is using contraception
Description

Gender | Pregnancy | Breast Feeding | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0700589
has the patient been diagnosed with a non-melanoma skin cancer (basal cell carcinoma bcc or squamous cell carcinoma scc) for which the chosen therapeutic option is surgical excision followed by secondary intention healing
Description

Malignant neoplasm of skin | Basal cell carcinoma | Squamous cell carcinoma | Therapeutic procedure Excision Wound healing status: secondary intention

Data type

boolean

Alias
UMLS CUI [1]
C0007114
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0007137
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0728940
UMLS CUI [4,3]
C0518863
is the excisional wound greater than 10mm x 10mm in size and less than or equal to 35mm x 35mm after any attempt at primary closure
Description

Measurement of wound size Excisional | primary closure

Data type

boolean

Alias
UMLS CUI [1,1]
C3853328
UMLS CUI [1,2]
C0728940
UMLS CUI [2]
C0441503
does the patient have limited skin laxity which would make primary closure of the surgical excision difficult
Description

Cutis Laxa Limited | Excision primary closure Difficult

Data type

boolean

Alias
UMLS CUI [1,1]
C0010495
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0441503
UMLS CUI [2,3]
C0332218
is the patient able to understand the aims and objectives of the trial and are they willing to consent
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has the patient been diagnosed with any transmittable viral diseases (hiv, hepatitis b or c)
Description

Virus Diseases | disease transmission | HIV | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0042769
UMLS CUI [2]
C0242781
UMLS CUI [3]
C0019682
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
has the patient been diagnosed with, or is it suspected that they have metastatic disease
Description

Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C2939420
does the patient have a history of malignant melanoma or any concomitant disease likely to impede wound healing
Description

melanoma | Comorbidity Preventing Wound Healing

Data type

boolean

Alias
UMLS CUI [1]
C0025202
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0043240
has the patient been diagnosed with pre-existing wound infection
Description

Wound Infection Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0043241
UMLS CUI [1,2]
C2347662
is the patient taking any medication known to interfere with skin grafts (i.e. warfarin and other anticoagulants, steroids, nsaids and immunosuppressants)
Description

Pharmaceutical Preparations Interferes with Transplanted skin | Warfarin | Anticoagulants | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0040748
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0003280
UMLS CUI [4]
C0038317
UMLS CUI [5]
C0003211
UMLS CUI [6]
C0021081
has the excised wound been entirely treated by primary closure
Description

Wound Excisional Treated with primary closure

Data type

boolean

Alias
UMLS CUI [1,1]
C0332803
UMLS CUI [1,2]
C0728940
UMLS CUI [1,3]
C0332293
UMLS CUI [1,4]
C0441503
does the patient have a history of any significant cardiac, pulmonary, renal, hepatic, neurological and/ or immune dysfunction that may affect wound healing
Description

Dysfunction Affecting Wound Healing | Cardiac dysfunction | Pulmonary Dysfunction | Renal dysfunction | Liver Dysfunction | Neurological Deficit or Dysfunction | Immune System Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C3887504
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0043240
UMLS CUI [2]
C3277906
UMLS CUI [3]
C1709770
UMLS CUI [4]
C3279454
UMLS CUI [5]
C0086565
UMLS CUI [6]
C1709219
UMLS CUI [7]
C0021053
does the patient know of any allergy to any of the device materials to be used in the trial
Description

Hypersensitivity Investigational Medical Device Materials

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2346570
UMLS CUI [1,3]
C0520510
does the patient have a known history of poor compliance with medical treatment
Description

Poor compliance Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0087111
has the patient participated in this trial previously and healed or been withdrawn
Description

Study Subject Participation Status | Healed | Withdrawn

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0205249
UMLS CUI [3]
C0424092
is the patient currently participating in any other clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Non-melanoma Skin Cancer NCT02409628

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
is the patient at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy | Breast Feeding | Contraceptive methods
Item
is the patient male, or is not pregnant or lactating and is using contraception
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Malignant neoplasm of skin | Basal cell carcinoma | Squamous cell carcinoma | Therapeutic procedure Excision Wound healing status: secondary intention
Item
has the patient been diagnosed with a non-melanoma skin cancer (basal cell carcinoma bcc or squamous cell carcinoma scc) for which the chosen therapeutic option is surgical excision followed by secondary intention healing
boolean
C0007114 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0007137 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
C0518863 (UMLS CUI [4,3])
Measurement of wound size Excisional | primary closure
Item
is the excisional wound greater than 10mm x 10mm in size and less than or equal to 35mm x 35mm after any attempt at primary closure
boolean
C3853328 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0441503 (UMLS CUI [2])
Cutis Laxa Limited | Excision primary closure Difficult
Item
does the patient have limited skin laxity which would make primary closure of the surgical excision difficult
boolean
C0010495 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2,1])
C0441503 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Comprehension Study Protocol | Informed Consent
Item
is the patient able to understand the aims and objectives of the trial and are they willing to consent
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Virus Diseases | disease transmission | HIV | Hepatitis B | Hepatitis C
Item
has the patient been diagnosed with any transmittable viral diseases (hiv, hepatitis b or c)
boolean
C0042769 (UMLS CUI [1])
C0242781 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
Metastatic Neoplasm
Item
has the patient been diagnosed with, or is it suspected that they have metastatic disease
boolean
C2939420 (UMLS CUI [1])
melanoma | Comorbidity Preventing Wound Healing
Item
does the patient have a history of malignant melanoma or any concomitant disease likely to impede wound healing
boolean
C0025202 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0043240 (UMLS CUI [2,3])
Wound Infection Pre-existing
Item
has the patient been diagnosed with pre-existing wound infection
boolean
C0043241 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Pharmaceutical Preparations Interferes with Transplanted skin | Warfarin | Anticoagulants | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Immunosuppressive Agents
Item
is the patient taking any medication known to interfere with skin grafts (i.e. warfarin and other anticoagulants, steroids, nsaids and immunosuppressants)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0040748 (UMLS CUI [1,3])
C0043031 (UMLS CUI [2])
C0003280 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
C0021081 (UMLS CUI [6])
Wound Excisional Treated with primary closure
Item
has the excised wound been entirely treated by primary closure
boolean
C0332803 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0332293 (UMLS CUI [1,3])
C0441503 (UMLS CUI [1,4])
Dysfunction Affecting Wound Healing | Cardiac dysfunction | Pulmonary Dysfunction | Renal dysfunction | Liver Dysfunction | Neurological Deficit or Dysfunction | Immune System Diseases
Item
does the patient have a history of any significant cardiac, pulmonary, renal, hepatic, neurological and/ or immune dysfunction that may affect wound healing
boolean
C3887504 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0043240 (UMLS CUI [1,3])
C3277906 (UMLS CUI [2])
C1709770 (UMLS CUI [3])
C3279454 (UMLS CUI [4])
C0086565 (UMLS CUI [5])
C1709219 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
Hypersensitivity Investigational Medical Device Materials
Item
does the patient know of any allergy to any of the device materials to be used in the trial
boolean
C0020517 (UMLS CUI [1,1])
C2346570 (UMLS CUI [1,2])
C0520510 (UMLS CUI [1,3])
Poor compliance Therapeutic procedure
Item
does the patient have a known history of poor compliance with medical treatment
boolean
C0032646 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Study Subject Participation Status | Healed | Withdrawn
Item
has the patient participated in this trial previously and healed or been withdrawn
boolean
C2348568 (UMLS CUI [1])
C0205249 (UMLS CUI [2])
C0424092 (UMLS CUI [3])
Study Subject Participation Status
Item
is the patient currently participating in any other clinical trial
boolean
C2348568 (UMLS CUI [1])
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