ID

23429

Descrição

Responsible Party: Dr. Marcus Redaèlli, Administative and scientific head of staffed offices of Interdisciplinary Centre for Health Services Research, University of Witten/Herdecke ClinicalTrials.gov Identifier: NCT01611207 History of Changes Other Study ID Numbers: 03-2012 DRKS ID 00003498 ( Registry Identifier: German Clinical Trials Register ) Study First Received: March 28, 2012 Last Updated: May 17, 2013 Evaluate the Efficacy of the Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) After Surgery by Application of Negative Pressure Wound Therapy (NPWT) in Comparison to Standard Conventional Wound Therapy (SCWT) of the Clinical Routine (ISAW) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01611207

Link

https://clinicaltrials.gov/ct2/show/NCT01611207

Palavras-chave

Versões (1)
  1. 04/07/2017 04/07/2017 -
Transferido a

4 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Wound Therapy After Surgery NCT01611207 DRKS ID 00003498

Inglês

Eligibility Wound Therapy After Surgery NCT01611207 DRKS ID 00003498

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Acute subcutaneous abdominal wound-healing impairment after surgical intervention
Descrição

Wound-healing

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043240
Sizes of wound opening (maximum diameter ≥ 3 cm)
Descrição

Wound Diameter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C1301886
Wound surface ≥ 9 qcm
Descrição

Wound surface

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0205148
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
Descrição

Infrastructure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1998546
Healthy Volunteers
Descrição

Control Group

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009932
Existence of an open abdominal fascia
Descrição

Open abdominal fascia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0225222
UMLS CUI [1,2]
C0332798
Acute serious organ failure
Descrição

Organ failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0231174
Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
Descrição

Start of Vacuum Device

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1690010
UMLS CUI [1,2]
C0439659
Ongoing / during 3 weeks after chemo therapy
Descrição

Ongoing after chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0392920
Ongoing / during 3 weeks after radiation therapy Contraindications in accordance with the safety precautions issued by the FDA or the companies
Descrição

Ongoing after radiotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1522449
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Similar models

Eligibility Wound Therapy After Surgery NCT01611207 DRKS ID 00003498

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Ages Eligible for Study: 18 Years and older (Adult, Senior)
boolean
C0001779 (UMLS CUI [1])
Wound-healing
Item
Acute subcutaneous abdominal wound-healing impairment after surgical intervention
boolean
C0043240 (UMLS CUI [1])
Wound Diameter
Item
Sizes of wound opening (maximum diameter ≥ 3 cm)
boolean
C0043250 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Wound surface
Item
Wound surface ≥ 9 qcm
boolean
C0043250 (UMLS CUI [1,1])
C0205148 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Infrastructure
Item
Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
boolean
C1998546 (UMLS CUI [1])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Open abdominal fascia
Item
Existence of an open abdominal fascia
boolean
C0225222 (UMLS CUI [1,1])
C0332798 (UMLS CUI [1,2])
Organ failure
Item
Acute serious organ failure
boolean
C0231174 (UMLS CUI [1])
Start of Vacuum Device
Item
Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
boolean
C1690010 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Ongoing after chemotherapy
Item
Ongoing / during 3 weeks after chemo therapy
boolean
C0549178 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Ongoing after radiotherapy
Item
Ongoing / during 3 weeks after radiation therapy Contraindications in accordance with the safety precautions issued by the FDA or the companies
boolean
C0549178 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
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