Discharged With Indwelling Chest Tube and Valve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2023-11-20

Brief Summary

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This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

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Detailed Description

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This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be screened prior to discharging from the hospital and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained the subject will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. The subject will be followed until they have their chest tube removed.

Conditions

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Prolonged Air Leak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Oral Antibiotics

Group Type ACTIVE_COMPARATOR

Oral Antibiotics-Close Monitoring

Intervention Type OTHER

To receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve.

Group 2

Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

Interventions

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Oral Antibiotics-Close Monitoring

To receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve.

Intervention Type OTHER

Standard of Care

No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years of age
* Male and Female
* Consultation with a thoracic surgeon
* Discharge from the hospital with a chest tube and valve in place
* Subject is able to understand the study procedures and provide informed consent.

Exclusion Criteria

* Pregnancy
* Allergy to Keflex and Clindamycin
* Special consideration should be taken in enrolling subjects with preexisting conditions that can be exacerbated by antibiotic use but are allowed at the discretion of the treating physician.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No