Monitoring and Treatment of Extremity Trauma for Mass Cas... | NCT01779011

Studies
Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts

NCT01779011

Sponsor

Alliance for International Medical Action

Status

Completed

Last Update Posted

Jan 29, 2013Estimated

Enrollment

305Actual

Phase

Not provided

Conditions

Wounds and Injuries
Traumatic Amputation

Interventions

Not provided

Countries

Haiti

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Dec 15, 2012

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2013

Last Update Posted Date

Jan 29, 2013Estimated

Name	Class
Lille Economie Management UMR CNRS 8157	UNKNOWN
National Research Agency, France	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The prospective cohort study, SuTra2, assesses the functional and socio-economic status of patients who were operated on for a severe limb injury resulting in amputation or limb preservation 1 and 2 years after the 2010 Haiti earthquake.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

305Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A cohort post amputation		Those patients undergoing either traumatic amputation or surgical amputation of limb
A cohort post limb conserving surgery		Patients whose surgical management involved conservation of their injured limb

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Satisfaction with Musculoskeletal functional recovery		2 years

Secondary Outcomes

Measure	Description	Time Frame
Employment status		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, with limb injuries due to the earthquake,
Who underwent limb surgery, which ended up in limb amputation or limb conservation.

Exclusion criteria :

Limb injury not related to the earthquake
No surgery for the limb injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients will be recruited by phone from databases issued by:

A surgical clinic, The Clinique Lambert (Pétion-Ville, Haiti),
Two non-governmental organizations
- Handicap International (HI)
- Bangladesh Rural Advancement Committee (BRAC),
A local organization l'Union des Jeunes Victimes du Séisme (UJVS)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Christine Delauche, MD	Alliance for International Medical Action	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ALIMA		Port-au-Prince	Port-au-Prince		Haiti

References Module

Citations

Not provided

ID	Term
D014947	Wounds and Injuries
D000673	Amputation, Traumatic