Silastic Versus Conventional Drain in Thoracic Surgery (SD-CD)

T.C. Dumlupınar Üniversitesi

Status: Completed

Conditions: Air Leak From Lung; Post Procedural Persistent Drain Fluid

Treatments: Procedure: Silastic vs conventional drain in thoracic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03056716

Silastic vs conventional drain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Silastic drain

Experimental group

Description:

Placement of 19FR silastic drain as basal drain

Treatment:

Procedure: Silastic vs conventional drain in thoracic surgery

Conventional drain

Active Comparator group

Description:

Placement of 32FR conventional drain as basal drain

Treatment:

Procedure: Silastic vs conventional drain in thoracic surgery