1- Objectives: The goal of this trial is to evaluate the efficiency of penetrating wound treatment without tube thoracostomy.
2- Design: The sampling begins in the emergency department. After qualifying the inclusion criteria and obtaining the informed consent, the patients enter the trial process.
3- Setting and conduct: Patients with penetrating thoracic trauma who are hemodynamically stable, undergo wound exploration. If the wound has relation to the pleuretic space, a suction tube is inserted into the thoracic cavity and the containing is suctioned in both seated and supine positions and then the suction tube is taken out with supporting Vaseline dressing like when a chest tube is taken out and the wound is dressed so that no air could get back into the thoracic cavity. In order to confirm that no pneumothorax is left, a CXR is taken. Chest auscultation is done by the physician every hour after admission and chest tube is inserted if any sound decrease or pneumothorax occurs. Otherwise if no sound decrease and/or pneumothorax is found, the patient is admitted and discharged after 48 hour if no problem has been occurred.
4- Participants including major eligibility criteria: Participants are selected among the patients admitted in the emergency department of Tabriz Emam Reza hospital. Inclusion criteria: Isolated thoracic injury in a hemodynamically stable patient. Exclusion criteria: Hemodynamic instability; concurrent thoracic and abdominal trauma; multiple penetrating thoracic injuries; emergent thoracotomy indication.
5- Intervention: Insertion of a suction tube through the penetrating wound and suctioning the pleural space
6- Variables: The studied variable is creation or remaining of pneumothorax or hemothorax which is confirmed by examination or chest X-ray.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111911534N1
Registration date:2013-03-12, 1391/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-12, 1391/12/22
Registrant information
Name
Keivan Kashy Zonouzy
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 6950
Email address
keivan293@irimc.org
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz university of medical sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of penetrating chest wound treatment with and without tube thoracostomy
Public title
Penetrating chest wound management without tube thoracostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Isolated thoracic injury in a hemodynamically stable patient.
Exclusion criteria: Hemodynamic instability; concurrent thoracic and abdominal trauma; Multiple penetrating thoracic injuries; Emergent thoracotomy indication.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences, Daneshgah Avenue
City
Tabriz
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
91144
Health conditions studied
1
Description of health condition studied
Thoracic penetrating trauma
ICD-10 code
S21.9
ICD-10 code description
Open wound of thorax, part unspecified
Primary outcomes
1
Description
Pneumothorax
Timepoint
On emergency department arrival and then every hour
Method of measurement
Chest auscultation by physician and confirmation by anterolateral chest X-ray graphy
Secondary outcomes
1
Description
Hemothorax
Timepoint
On admission in surgery ward and then every hour
Method of measurement
Chest auscultation by physician and confirmation by anterolateral chest X-ray graphy
Intervention groups
1
Description
Suction tube insertion within the site of thoracic penetrating trauma wound and suction of the pleura containing
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital of Tabriz
Full name of responsible person
Dr Keivan Kashy Zonouzy
Street address
Emam Reza educational and therapeutic center, Daneshgah avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz university of medical sciences
Full name of responsible person
Dr Shahriar Hashemzadeh
Street address
Emam Reza hospital, Daneshgah avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tabriz university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Shahriar Hashemzadeh
Position
Thoracic surgeon, Associate professor of Tabriz university of medical sciences
Other areas of specialty/work
Street address
Surgery group office, 2nd floor, Emam Reza educational and therapeutic center, Daneshgah avenue
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
+98 41 1334 6762
Email
shahriar_90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Shahriar Hashemzadeh
Position
Thoracic sugeon, Associate professor of Tabriz university of medical sciences
Other areas of specialty/work
Street address
Surgery group office, 2nd floor, Emam Reza educational and therapeutic center, Daneshgah avenue
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
+98 41 1334 6762
Email
shahriar_90@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Keivan Kashy Zonouzy
Position
Chief resident of general surgery - Tabriz university of medical sciences
Other areas of specialty/work
Street address
Surgery group office, 2nd floor, Emam Reza educational and therapeutic center, Daneshgah avenue
City
Tabriz
Postal code
Phone
+98 41 1334 8130
Fax
+98 41 1334 6762
Email
keivan293@irimc.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)