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Trial registered on ANZCTR


Registration number
ACTRN12616001110471
Ethics application status
Approved
Date submitted
22/07/2016
Date registered
16/08/2016
Date last updated
16/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Usefulness of flexible silicone drainage versus conventional plastic drainage in thoracic surgery.
Scientific title
Usefulness of flexible silicone drainage versus conventional plastic drainage in thoracic surgery.
Secondary ID [1] 289733 0
None
Universal Trial Number (UTN)
U1111-1185-6444
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pleural drainages 299575 0
Postoperative in thoracic surgery 299576 0
Condition category
Condition code
Respiratory 299545 299545 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two groups of study were made:
- Group A was composed by patients with a conventional drainage (24Fr medovations straight thorax tube).
- Group B was composed by patients that had a soft silicone drainage (24Fr BiovacTM round silicone fluted drain).

Silicone drainages are softer and each of their sections has a different shape, longitudinally slotted in the proximal sections that work through capillary action, and round-shaped in distal sections, in order to avoid any possible obstruction. In early studies their main inconvenience the complications that appeared when evacuating air where there is a persistent air leak. Passively aspirational conventional drainages were considered the most suitable option for patients with a small air leak and the actively aspirational ones for treating patients with a major air leak. After Lung resection one Or two drainages are inserted for 3 Or 4 days. The silicone drainage is used in cardiothoracic surgery and general surgery.

The number of days that drainage have to stay depend of x-ray and this decision is taken by thoracic surgeon
Intervention code [1] 295370 0
Treatment: Devices
Comparator / control treatment
The comparator group was composed by patients with a conventional drainage (24Fr medovations straight thorax tube).
Control group
Active

Outcomes
Primary outcome [1] 299024 0
Pneumothorax, assessed by x-ray.
Timepoint [1] 299024 0
24 hours Postoperative thorax radiography
Primary outcome [2] 299025 0
Pleural effusion, assessed by x-ray.
Timepoint [2] 299025 0
24 hours Postoperative thorax radiography
Secondary outcome [1] 325889 0
Air leak, assessed using the pleur-evac system.
Timepoint [1] 325889 0
5 days post procedure.
Secondary outcome [2] 325890 0
Days with drainage in place, assessed by review of medical records.
Timepoint [2] 325890 0
At time of drainage removal postoperatively.
Secondary outcome [3] 325891 0
subcutaneous emphysema, assessed by x-ray.
Timepoint [3] 325891 0
24 hours postoperative x-ray.

Eligibility
Key inclusion criteria
The inclusion criteria are:
- Patients older than 18 years.
- Patients who agree to take part of this study.
- Patients who scheduled to undergo a pulmonary resection between January and June 2014.
- Patients younger than 80 years.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with coagulopathy, COPD history, interstitial lung disease, neoadjuvant chemotherapy, resections extended to the wall, bronchoplasty, and those who had a pneumonectomy performed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We used a randomisation by computer but allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We used permuted block randomisation design.

When patients agree to participate in our study, they are included in a database and with a computer generated program they are divided into two groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a open controlled randomized clinical trial was performed, in a homogenous sample.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We calculated the sample with nQuery Advisor Release 7.0 program with 5% of alfa error and 80% of power. The simple size was 100 patients. We used the incidense of pneumothorax posoperative to calculated the sample size.

The data were tabulated and analysed using chi square test for the qualitative variables and Student’s t test for the quantitative ones, so we can determine the statistical significance (SPSS 22.0).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8046 0
Spain
State/province [1] 8046 0
Seville

Funding & Sponsors
Funding source category [1] 294119 0
Hospital
Name [1] 294119 0
Virgen Macarena University Hospital.
Address [1] 294119 0
Av. Fedriani, 3.
41009 – Sevilla.

Country [1] 294119 0
Spain
Primary sponsor type
Hospital
Name
Virgen Macarena University Hospital
Address
Av. Fedriani, 3.
Hospital Universitario Virgen Macarena.
41009 – Sevilla.

Country
Spain
Secondary sponsor category [1] 292947 0
None
Name [1] 292947 0
None
Address [1] 292947 0
None
Country [1] 292947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295525 0
Virgen Macarena University Hospital Ethics committee
Ethics committee address [1] 295525 0
Av. Fedriani, 3.
Virgen Macarena University Hospital. .
41009 – Sevilla.

Ethics committee country [1] 295525 0
Spain
Date submitted for ethics approval [1] 295525 0
03/01/2012
Approval date [1] 295525 0
30/01/2012
Ethics approval number [1] 295525 0
1728

Summary
Brief summary
The pleural drainage’s main objective is to restore the negative pressure in the pleural cavity and evacuate the liquid and air remaining after surgery, apart from allowing an early detection of possible complications. The first person to use them routinely in post thorax surgery patients was Lilienthal in 1922. Since then, several types of drainage have been created and today the most commonly used is the semi-rigid plastic drainage with active or passive aspiration, whose main inconvenient is that, since they are rigid, they cause pain after surgery, not allowing the patient to move in the early days and making it difficult for them to get back to their ventilatory dynamics. So it increases the length of the hospital stay. Because of this, soft silicone drainages were introduced, given that the patients adapt to them better but, despite this, they have not been widely spread due to a lack of studies that confirm their usefulness for both liquid and air drainage.
Silicone drainages are softer and each of their sections has a different shape, longitudinally slotted in the proximal sections that work through capillary action, and round-shaped in distal sections, in order to avoid any possible obstruction. In early studies their main inconvenient was the complications that appeared when evacuating air where there is a persistent air leak. Passively aspirational conventional drainages were considered the most suitable option for patients with a small air leak and the actively aspirational ones for treating patients with a major air leak.
This is why a randomized clinical trial was performed so we can determine the usefulness of soft silicone drainages in post-operative thorax surgery.
.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 968 968 0 0

Contacts
Principal investigator
Name 67618 0
Miss Nathalie Pinos
Address 67618 0
Av. Fedriani, 3.
Virgen Macarena University Hospital. .
41009 – Sevilla.

Country 67618 0
Spain
Phone 67618 0
+34 955008206.
Fax 67618 0
+34 955008205.
Email 67618 0
nathaliepinos@hotmail.com
Contact person for public queries
Name 67619 0
Dr Miguel Congregado
Address 67619 0
Av. Fedriani, 3.
Virgen Macarena University Hospital. .
41009 – Sevilla.
Country 67619 0
Spain
Phone 67619 0
+34 955008206.
Fax 67619 0
+34 955008205.
Email 67619 0
mcongregado@us.es
Contact person for scientific queries
Name 67620 0
Dr Sergio Moreno
Address 67620 0
Av. Fedriani, 3.
Virgen Macarena University Hospital. .
41009 – Sevilla.
Country 67620 0
Spain
Phone 67620 0
+34 955008206.
Fax 67620 0
+34 955008205.
Email 67620 0
sergiobmm@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary