WoundsNCT01454167
Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications
An observational study of Wounds and Infections, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds, Infections, Seroma
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all post operational patients who have a vacuum drain/s
Who may be able to join
- all post operational patients who have a vacum drain/s
Who cannot join
- patients who are unable to sign a Consent Form (demented,Alzheimer's disease ...)
- patients who refuse participation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa
Nir Gal Or, nirgalor@gmail.com
Nir Gal Or, Dr
About this study
Official title: Acid Base and Electrolytes Patterns in Drains of Different Operational Wounds and Its Relation to Specific Infections and Seroma Formation
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.
Read the 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.
- Conditions
- Wounds, Infections, Seroma
- Keywords
- vacum drains, operational wounds, infections, seroma, acid base, glucose, lactate
- Medical subject headings
- Wounds and Injuries, Infections, Seroma
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological confirmation
Measured: end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startMay 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaron Har-Shai, Carmel Medical Center
- Investigators
- Nir Gal Or, Dr, Principal investigator, carmel medical center- ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454167
- Sponsor's protocol ID
- CMC-13-0130-CTIL
- Status last verified
- May 2015
- First submitted
- 14 Oct 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid Base and Electrolytes Patterns in Drains of Different Operational Wounds and Its Relation to Specific Infections and Seroma Formation
- ClinicalTrials.gov ID
- NCT01454167
- Acronym / sponsor ID
- CMC-13-0130-CTIL
- Conditions
- Wounds, Infections, Seroma
- Keywords
- vacum drains, operational wounds, infections, seroma, acid base, glucose, lactate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all post operational patients who have a vacuum drain/s
Key inclusion criteria (1 listed)
- all post operational patients who have a vacum drain/s
Key exclusion criteria (2 listed)
- patients who are unable to sign a Consent Form (demented,Alzheimer's disease ...)
- patients who refuse participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histological confirmation
Time frame: end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Gal Or, Dr principal investigator
carmel medical center- ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Infections, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nir Gal Or, Dr (0545454636, nirgalor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological confirmation (time frame: end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.