Acid Base and Electrolytes Patterns in Drains Operational... | NCT01454167

Studies
Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications

NCT01454167

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

May 27, 2015Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Wounds
Infections
Seroma

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Oct 14, 2011

First Submission Date that Met QC Criteria

Oct 17, 2011

First Posted Date

Oct 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2015

Last Update Posted Date

May 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective- The purpose of this study is to evaluate a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacuum drains of different plastic operational wounds and its relation to infections and seroma formation.

Detailed Description

our objective is evaluation of a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacum drains of different plastic operational wounds and its relation to infections and seroma formation.

it is possible that early changes in this values might point out an infection or seroma formation of a wound before clinical signs appear.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Measure	Description	Time Frame
Histological confirmation		end of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all post operational patients who have a vacum drain/s

Exclusion Criteria:

patients who are unable to sign a Consent Form (demented,Alzheimer's disease ...)
patients who refuse participation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

all post operational patients who have a vacuum drain/s

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nir Gal Or, Dr	Contact	0545454636		nirgalor@gmail.com

Overall Officials

Name	Affiliation	Role
Nir Gal Or, Dr	carmel medical center- ISRAEL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D007239	Infections
D049291	Seroma

Ancestor Terms

ID	Term
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided