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

• ClinicalTrials.gov Identifier: NCT03056716
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: February 20, 2017
• Sponsor: T.C. Dumlupınar Üniversitesi
• Collaborator: Bursa Yüksek İhtisas Education and Research Hospital
• Information provided by (Responsible Party): Serhat Yalcinkaya,MD, T.C. Dumlupınar Üniversitesi

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Air Leak From Lung; Post Procedural Persistent Drain Fluid	Procedure: Silastic vs conventional drain in thoracic surgery	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.
• Actual Study Start Date: June 2009
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Turkey

Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, Yildirim, Turkey, 16330

Sponsors and Collaborators

T.C. Dumlupınar Üniversitesi

Bursa Yüksek İhtisas Education and Research Hospital

More Information

• Responsible Party: Serhat Yalcinkaya,MD, Assist. Prof. of Thoracic Surgery, T.C. Dumlupınar Üniversitesi
• ClinicalTrials.gov Identifier: NCT03056716
• Other Study ID Numbers: Silastic vs conventional drain
• First Posted: February 17, 2017
• Last Update Posted: February 20, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient data except for the names and ID numbers will be shared.

• 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

Keywords provided by Serhat Yalcinkaya,MD, T.C. Dumlupınar Üniversitesi:

thoracic surgery; silastic drains; conventional drains