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Silastic Versus Conventional Drain in Thoracic Surgery

Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03056716
Acronym
SD-CD
Enrollment
118
Registered
2017-02-17
Start date
2009-06-30
Completion date
2012-12-31
Last updated
2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air Leak From Lung, Post Procedural Persistent Drain Fluid

Keywords

thoracic surgery, silastic drains, conventional drains

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.

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.

Interventions

PROCEDURESilastic 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.

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
CollaboratorOTHER_GOV
T.C. Dumlupınar Üniversitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of hospital stay3 yearsDuration of hospital stay will be noted on the study datasheet and will be measured in days.

Secondary

MeasureTime frameDescription
Daily amount of fluid drainage3 yearsDaily amount of fluid drainage will be measured in mililiters during the daily rounds everyday, and will be noted on the datasheet.
Duration of fluid drainage3 yearsEveryday 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.
Duration of air leak3 yearsEveryday 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026