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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00298259

Registration number

NCT00298259

Ethics application status

Date submitted

1/03/2006

Date registered

2/03/2006

Date last updated

11/12/2012

Titles & IDs

Public title

Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest

Scientific title

Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest

Secondary ID [1]

50/06

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Flail Chest

Ventilation

Condition category

Condition code

Injuries and Accidents

Fractures

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Surgery - operative fixation of fractured ribs

Active comparator: ORIF - open reduction internal fixation of fractured ribs in flail chest patients

No intervention: conservative management - current standard conservative management

Treatment: Surgery: operative fixation of fractured ribs
ORIFof fractured ribs in flail chest patients

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Mechanical ventilation hours

Timepoint [1]

open

Primary outcome [2]

intensive care stay hours

Timepoint [2]

open

Eligibility

Key inclusion criteria

* patients with multiple (>3) fractured ribs between the level of ribs 3 to 10 resulting in a paradoxical movement of the chest wall -

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* age > 75 years
* Spinal injuries which would preclude placement of the patient in a lateral decubitus position
* Open rib fractures with soiling or infection
* Severe head injury
* Uncorrected coagulopathy
* Adult respiratory distress syndrome
* Sepsis

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2007

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/03/2012

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

3181 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

The Alfred

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Background: Fracture of several ribs in more than one place as the result of trauma, leads to paradoxical movement of the chest wall and ventilatory failure. The mainstay of management in these patients has traditionally been analgesia and positive pressure ventilation to splint the chest wall and allow healing of the ribs to begin. However, this management option leads to prolonged intensive care unit (ICU) stay with increasing complication rates as patients remain on a ventilator for prolonged periods. Patients often remain on a ventilator for two to three weeks while waiting for enough rib healing to provide sufficient chest wall stability to allow the patient to take over all their breathing themselves. Until that time, patients are at risk of pneumonia and sepsis and other complications. Long term disabilities which have been reported in these patients include ongoing pain syndromes, inability to return to work, particularly manual type labour and cosmetic chest wall deformities.

An alternative treatment strategy is to operatively fix the ribs. By fixing the ribs operatively, the patient no longer requires internal pneumatic stabilization (provided by mechanical ventilation) and can be weaned from the ventilator within days rather than weeks. This can potentially lead to earlier discharge from the intensive care unit, and an avoidance of the multiple complications which arise in the ventilated patient. Rib fixation may also lead to less pain and deformity, improved mobility in the post injury phase and earlier return to work.

Hypothesis: that early operative fixation of ribs in patients presenting with flail chest secondary to trauma will result in less mechanical ventilatory requirements, earlier discharge from the intensive care unit and lower rate of complications associated with prolonged mechanical ventilation. This will lead to cost savings in the treatment of these patients.

Trial website

https://clinicaltrials.gov/study/NCT00298259

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Silvana Marasco, FRACS

Address

The Alfred

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00298259

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00298259