ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

U1111-1185-6444

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pleural drainages

Postoperative in thoracic surgery

Condition category

Condition code

Respiratory

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]

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]

Pneumothorax, assessed by x-ray.

Timepoint [1]

24 hours Postoperative thorax radiography

Primary outcome [2]

Pleural effusion, assessed by x-ray.

Timepoint [2]

24 hours Postoperative thorax radiography

Secondary outcome [1]

Air leak, assessed using the pleur-evac system.

Timepoint [1]

5 days post procedure.

Secondary outcome [2]

Days with drainage in place, assessed by review of medical records.

Timepoint [2]

At time of drainage removal postoperatively.

Secondary outcome [3]

subcutaneous emphysema, assessed by x-ray.

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

7/01/2014

Date of last participant enrolment

Anticipated

Actual

30/06/2014

Date of last data collection

Anticipated

Actual

4/07/2014

Sample size

Target

100

Accrual to date

Final

100

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Seville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Virgen Macarena University Hospital.

Address [1]

Av. Fedriani, 3.
41009 – Sevilla.

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Virgen Macarena University Hospital Ethics committee

Ethics committee address [1]

Av. Fedriani, 3.
Virgen Macarena University Hospital.  .
41009 – Sevilla.

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

03/01/2012

Approval date [1]

30/01/2012

Ethics approval number [1]

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]

/AnzctrAttachments/371140-1728.pdf

Contacts

Principal investigator

Name

Miss Nathalie Pinos

Address

Av. Fedriani, 3.
Virgen Macarena University Hospital. .
41009 – Sevilla.

Country

Spain

Phone

+34 955008206.

Fax

+34 955008205.

nathaliepinos@hotmail.com

Contact person for public queries

Name

Miguel Congregado

Address

Av. Fedriani, 3.
Virgen Macarena University Hospital. .
41009 – Sevilla.

Country

Spain

Phone

+34 955008206.

Fax

+34 955008205.

mcongregado@us.es

Contact person for scientific queries

Name

Sergio Moreno

Address

Av. Fedriani, 3.
Virgen Macarena University Hospital. .
41009 – Sevilla.

Country

Spain

Phone

+34 955008206.

Fax

+34 955008205.

sergiobmm@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically