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

Silastic Versus Conventional Drain for Postoperative Drainage 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.

Study Overview

• Status: Completed
• Conditions: Air Leak From Lung; Post Procedural Persistent Drain Fluid
• Intervention / Treatment: Procedure: Silastic vs conventional drain in thoracic surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yildirim
    • Bursa, Yildirim, Turkey, 16330
      • Bursa Yuksek Ihtisas Research and Education Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silastic drain; Placement of 19FR silastic drain as basal drain	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.
Active Comparator: Conventional drain; Placement of 32FR conventional drain as basal drain	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay	Duration of hospital stay will be noted on the study datasheet and will be measured in days.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: T.C. Dumlupınar Üniversitesi
• Collaborators: Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: thoracic surgery; silastic drains; conventional drains
• Other Study ID Numbers: Silastic vs conventional drain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient data except for the names and ID numbers will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes