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Usefulness of flexible silicone drainage versus conventional plastic drainage in thoracic surgery.

Usefulness of flexible silicone drainage versus conventional plastic drainage in thoracic surgery.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001110471
Enrollment
100
Registered
2016-08-16
Start date
2014-01-07
Completion date
2014-06-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. .

Interventions

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

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

Sponsors

Virgen Macarena University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026