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NCT Number: NCT03056716

Silastic Versus Conventional Drain 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.

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Key information

Conditions

Air Leak From Lung Post Procedural Persistent Drain Fluid

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, Yildirim, 16330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidates of surgery willing to participate in the experimental arm of the study and signing the informed consent form.

Exclusion criteria

  • Pneumonectomy, diaphragm plication, and decortication candidates

Treatment and study plan

Silastic vs conventional drain in thoracic surgery

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Daily amount of fluid drainage

    Time frame: 3 years

    Daily amount of fluid drainage will be measured in mililiters during the daily rounds everyday, and will be noted on the datasheet.

  2. Duration of fluid drainage

    Time frame: 3 years

    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.

  3. Duration of air leak

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

T.C. Dumlupınar Üniversitesi

Other

Collaborators

  • Bursa Yuksek Ihtisas Training and Research Hospital

Registry information

Official study title

Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.

Acronym: SD-CD

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2017
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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