Silastic Versus Conventional Drain in Thoracic Surgery

NCT03056716 | Completed

• 1 other identifier: Silastic vs conventional drain
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Air Leak From Lung; Post Procedural Persistent Drain Fluid

Keywords

thoracic surgery; silastic drains; conventional drains

Outcome Measures

Primary Outcomes (1)

• Duration of hospital stay

  Duration of hospital stay will be noted on the study datasheet and will be measured in days.

  3 years

Secondary Outcomes (3)

• Daily amount of fluid drainage

  3 years

• Duration of fluid drainage

  3 years

• Duration of air leak

  3 years

Study Arms (2)

Silastic drain

EXPERIMENTAL

Placement of 19FR silastic drain as basal drain

Procedure: Silastic vs conventional drain in thoracic surgery

Conventional drain

ACTIVE COMPARATOR

Placement of 32FR conventional drain as basal drain

Procedure: Silastic vs conventional drain in thoracic surgery

Interventions

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.

Conventional drain; Silastic drain

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pneumonectomy, diaphragm plication, and decortication candidates

Sponsors & Collaborators

• T.C. Dumlupınar Üniversitesi: lead
• Bursa Yuksek Ihtisas Training and Research Hospital: collaborator

Study Sites (1)

Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, Yildirim, 16330, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Thoracic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. of Thoracic Surgery

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 17, 2017
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)