Silastic Versus Conventional Drain in Thoracic Surgery

Air Leak From Lung Clinical Trial

— SD-CD  

Official title:

Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056716
• Other study ID #: Silastic vs conventional drain
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: February 16, 2017
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2017
• Source: T.C. Dumlupinar Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Air Leak From Lung
• Post Procedural Persistent Drain Fluid

Intervention

Procedure:
• Silastic vs conventional drain in thoracic surgery
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.

Locations

Country	Name	City	State
Turkey	Bursa Yuksek Ihtisas Research and Education Hospital	Bursa	Yildirim

Sponsors (2)

Lead Sponsor	Collaborator
T.C. Dumlupinar Üniversitesi	Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospital stay	Duration of hospital stay will be noted on the study datasheet and will be measured in days.	3 years
Secondary	Daily amount of fluid drainage	Daily amount of fluid drainage will be measured in mililiters during the daily rounds everyday, and will be noted on the datasheet.	3 years
Secondary	Duration of fluid drainage	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 years
Secondary	Duration of air leak	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.	3 years