ID

26570

Beschrijving

Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00768222

Link

https://clinicaltrials.gov/show/NCT00768222

Trefwoorden

Versies (2)
  1. 19-10-17 19-10-17 -
  2. 22-10-17 22-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 oktober 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT00768222

Engels

Eligibility Breast Cancer NCT00768222

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older with written informed consent
Beschrijving

Age | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
scheduled for a modified radical mastectomy
Beschrijving

Modified radical mastectomy Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024883
UMLS CUI [1,2]
C0205539
surgical wound classified class i/clean using the cdc ssi surgical wound classification
Beschrijving

Surgical wound Surgical wound classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332803
UMLS CUI [1,2]
C2038494
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit
Beschrijving

Informed Consent Unable | Protocol Compliance Unlikely | Follow-up visit Completion Unlikely

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
UMLS CUI [3,1]
C0589121
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C0750558
undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant
Beschrijving

Operative Surgical Procedures | Modified radical mastectomy | Mammaplasty Immediate | Breast cosmetic surgery | Cosmetic breast reduction | Cosmetic breast augmentation | Breast implant procedure | Mammary duct ectasia | Communicable Disease Breast | Infection of breast implant

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0024883
UMLS CUI [3,1]
C0085076
UMLS CUI [3,2]
C0205253
UMLS CUI [4]
C0549358
UMLS CUI [5]
C1390445
UMLS CUI [6]
C1390444
UMLS CUI [7]
C0178391
UMLS CUI [8]
C0152442
UMLS CUI [9,1]
C0009450
UMLS CUI [9,2]
C0006141
UMLS CUI [10]
C0405488
surgical wounds classified as class ii, iii or iv using cdc ssi surgical wound classification
Beschrijving

Surgical wound Surgical wound classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332803
UMLS CUI [1,2]
C2038494
has inflammatory cancers or skin ulceration
Beschrijving

Malignant Neoplasms inflammatory | Skin Ulcer inflammatory

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0333348
UMLS CUI [2,1]
C0037299
UMLS CUI [2,2]
C0333348
has known allergy or intolerance to triclosan
Beschrijving

Triclosan allergy | Intolerance to Triclosan

Datatype

boolean

Alias
UMLS CUI [1]
C0571330
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0040958
has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, aids or substance abuse
Beschrijving

Impaired wound healing | Immunologic Deficiency Syndromes chronic | Diabetes Mellitus | Steroid use Prolonged | AIDS | Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0151692
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0011849
UMLS CUI [4,1]
C0281991
UMLS CUI [4,2]
C0439590
UMLS CUI [5]
C0001175
UMLS CUI [6]
C0038586
has serious heart and/or lung disease
Beschrijving

Heart Disease Serious | Lung disease Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205404
has skin scar history or family history
Beschrijving

Skin Scar | Skin Scar Family history

Datatype

boolean

Alias
UMLS CUI [1]
C0241158
UMLS CUI [2,1]
C0241158
UMLS CUI [2,2]
C0241889
has direct relationship to or involvement in this or other studies under the direction of the investigator or center
Beschrijving

Study Subject Participation Status | Relationship Clinical Trial | Involvement with Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0008976
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0008976
received an experimental drug or device within 30 days prior to the planned start of treatment
Beschrijving

Investigational New Drugs | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
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Similar models

Eligibility Breast Cancer NCT00768222

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
18 years of age or older with written informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Modified radical mastectomy Scheduled
Item
scheduled for a modified radical mastectomy
boolean
C0024883 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Surgical wound Surgical wound classification
Item
surgical wound classified class i/clean using the cdc ssi surgical wound classification
boolean
C0332803 (UMLS CUI [1,1])
C2038494 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Protocol Compliance Unlikely | Follow-up visit Completion Unlikely
Item
unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0589121 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
Operative Surgical Procedures | Modified radical mastectomy | Mammaplasty Immediate | Breast cosmetic surgery | Cosmetic breast reduction | Cosmetic breast augmentation | Breast implant procedure | Mammary duct ectasia | Communicable Disease Breast | Infection of breast implant
Item
undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant
boolean
C0543467 (UMLS CUI [1])
C0024883 (UMLS CUI [2])
C0085076 (UMLS CUI [3,1])
C0205253 (UMLS CUI [3,2])
C0549358 (UMLS CUI [4])
C1390445 (UMLS CUI [5])
C1390444 (UMLS CUI [6])
C0178391 (UMLS CUI [7])
C0152442 (UMLS CUI [8])
C0009450 (UMLS CUI [9,1])
C0006141 (UMLS CUI [9,2])
C0405488 (UMLS CUI [10])
Surgical wound Surgical wound classification
Item
surgical wounds classified as class ii, iii or iv using cdc ssi surgical wound classification
boolean
C0332803 (UMLS CUI [1,1])
C2038494 (UMLS CUI [1,2])
Malignant Neoplasms inflammatory | Skin Ulcer inflammatory
Item
has inflammatory cancers or skin ulceration
boolean
C0006826 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0037299 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
Triclosan allergy | Intolerance to Triclosan
Item
has known allergy or intolerance to triclosan
boolean
C0571330 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0040958 (UMLS CUI [2,2])
Impaired wound healing | Immunologic Deficiency Syndromes chronic | Diabetes Mellitus | Steroid use Prolonged | AIDS | Substance Use Disorders
Item
has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, aids or substance abuse
boolean
C0151692 (UMLS CUI [1])
C0021051 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3])
C0281991 (UMLS CUI [4,1])
C0439590 (UMLS CUI [4,2])
C0001175 (UMLS CUI [5])
C0038586 (UMLS CUI [6])
Heart Disease Serious | Lung disease Serious
Item
has serious heart and/or lung disease
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Skin Scar | Skin Scar Family history
Item
has skin scar history or family history
boolean
C0241158 (UMLS CUI [1])
C0241158 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Study Subject Participation Status | Relationship Clinical Trial | Involvement with Clinical Trial
Item
has direct relationship to or involvement in this or other studies under the direction of the investigator or center
boolean
C2348568 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
Investigational New Drugs | Investigational Medical Device
Item
received an experimental drug or device within 30 days prior to the planned start of treatment
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
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