Air Leak From LungSD-CDNCT03056716
Silastic Versus Conventional Drain in Thoracic Surgery
A study testing Silastic vs conventional drain in thoracic surgery in people with Air Leak From Lung and Post Procedural Persistent Drain Fluid, run by T.C. Dumlupınar Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
In thoracic surgery, it is usual to place apical and basal drains for complete drainage of air and fluid out of the pleural cavity. The routinely used drains are mainly made of plastic. Recently silastic drains of smaller size are used without any complication. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Air Leak From Lung, Post Procedural Persistent Drain Fluid
- What is being tested?
- Silastic vs conventional drain in thoracic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2009to Dec 2012
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidates of surgery willing to participate in the experimental arm of the study and signing the informed consent form.
Who cannot join
- Pneumonectomy, diaphragm plication, and decortication candidates
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Research and Education Hospital
Bursa, Yildirim, 16330
About this study
Official title: Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.
In thoracic surgery, it is usual to place apical and basal drains for complete drainage of air and fluid out of the pleural cavity. The routinely used drains are mainly made of plastic. Recently silastic drains of smaller size are used without any complication. The investigators designed a prospective randomized trial to compare the draining properties of the two types of drains following various resections in thoracic surgery.
Read the detailed description
Following the Institutional Review Board permission (permission no: 2009/27) the investigators started to recruit patients for the study in June 2009. Pneumonectomy, decortication, and diaphragm plication patients were not included in this study. The patients were consecutively placed in one of the two groups. In Group I, an apical 28FR size CD, and a basal 19FR SD were placed following surgery. In Group II, the apical drain was 28FR, and the basal drain was 32FR CDs. Basal drains were removed out when daily serous fluid drainage became 200 ml or less, and the apical were removed 48-72 hours following the cessation of air leak. The patients were discharged on the day after drain removal. The data concerning gender, age, diagnosis, operation side, type of operation, amount of fluid drainage, duration of fluid and air drainage, length of hospital stay, and complications if any, were noted.
- Being tested
- Silastic vs conventional drain in thoracic surgery
- Keywords
- thoracic surgery, silastic drains, conventional drains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silastic vs conventional drain in thoracic surgeryProcedure or surgery
Apical drains will be identical in size and material, and the basal drains will be different in groups. The patients will be followed for daily amounts of fluid drainage, duration of air leaks and fluid drainage, and duration of hospitalization, and the results will be compared statistically to asses any possible relationships with the outcome and the type of basal drain used.
| Study group | Role | What they receive |
|---|---|---|
| Silastic drain | Experimental | Placement of 19FR silastic drain as basal drain Receives: Procedure: Silastic vs conventional drain in thoracic surgery |
| Conventional drain | Active comparator | Placement of 32FR conventional drain as basal drain Receives: Procedure: Silastic vs conventional drain in thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Duration of hospital stay will be noted on the study datasheet and will be measured in days.
Measured: 3 years
Secondary outcomes (3)
Daily amount of fluid drainage
Daily amount of fluid drainage will be measured in mililiters during the daily rounds everyday, and will be noted on the datasheet.
Measured: 3 years
Duration of fluid drainage
Everyday the drains will be checked for fluid drainage and the day without any drainage will be noted on the datasheet. Duration of fluid drainage will be measured in days since the postoperative day 1.
Measured: 3 years
Duration of air leak
Everyday the drains will be checked for air leaks and the day without any air leak will be noted on the datasheet. Duration of air leak will be measured in days since the postoperative day 1.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startJun 2009
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Leak From LungStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- T.C. Dumlupınar Üniversitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Principal investigator, Serhat Yalcinkaya,MD, T.C. Dumlupınar Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056716
- Sponsor's protocol ID
- Silastic vs conventional drain
- Acronym
- SD-CD
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient data except for the names and ID numbers will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.
- ClinicalTrials.gov ID
- NCT03056716
- Acronym / sponsor ID
- SD-CD / Silastic vs conventional drain
- Keywords
- thoracic surgery, silastic drains, conventional drains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- T.C. Dumlupınar ÜniversitesiUniversity, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- Jun 2009 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Feb 2017 (actual)
- 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.
In thoracic surgery, it is usual to place apical and basal drains for complete drainage of air and fluid out of the pleural cavity. The routinely used drains are mainly made of plastic. Recently silastic drains of smaller size are used without any complication. The investigators designed a prospective randomized trial to compare the draining properties of the two types of drains following various resections in thoracic surgery.
Detailed description
Following the Institutional Review Board permission (permission no: 2009/27) the investigators started to recruit patients for the study in June 2009. Pneumonectomy, decortication, and diaphragm plication patients were not included in this study. The patients were consecutively placed in one of the two groups. In Group I, an apical 28FR size CD, and a basal 19FR SD were placed following surgery. In Group II, the apical drain was 28FR, and the basal drain was 32FR CDs. Basal drains were removed out when daily serous fluid drainage became 200 ml or less, and the apical were removed 48-72 hours following the cessation of air leak. The patients were discharged on the day after drain removal. The data concerning gender, age, diagnosis, operation side, type of operation, amount of fluid drainage, duration of fluid and air drainage, length of hospital stay, and complications if any, were noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silastic drain | Experimental | Procedure: Silastic vs conventional drain in thoracic surgeryPlacement of 19FR silastic drain as basal drain |
| Conventional drain | Active comparator | Procedure: Silastic vs conventional drain in thoracic surgeryPlacement of 32FR conventional drain as basal drain |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates of surgery willing to participate in the experimental arm of the study and signing the informed consent form.
Key exclusion criteria (1 listed)
- Pneumonectomy, diaphragm plication, and decortication candidates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silastic vs conventional drain in thoracic surgeryApical drains will be identical in size and material, and the basal drains will be different in groups. The patients will be followed for daily amounts of fluid drainage, duration of air leaks and fluid drainage, and duration of hospitalization, and the results will be compared statistically to asses any possible relationships with the outcome and the type of basal drain used. | Procedure or surgery | Conventional drain, Silastic drain |
Primary outcome
Duration of hospital stay
Time frame: 3 years
Duration of hospital stay will be noted on the study datasheet and will be measured in days.
3 secondary outcomes
Daily amount of fluid drainage
Time frame: 3 years
Duration of fluid drainage
Time frame: 3 years
Duration of air leak
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Individual participant dataSharing planned: Yes. Patient data except for the names and ID numbers will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silastic vs conventional drain in thoracic surgery in people with Air Leak From Lung and Post Procedural Persistent Drain Fluid, run by T.C. Dumlupınar Üniversitesi at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 20 Feb 2017. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: 3 years). 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 20 Feb 2017.