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Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts (SuTra²)

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ClinicalTrials.gov Identifier: NCT01779011
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Wounds and Injuries Traumatic Amputation

Study Design

Study Type : Observational
Actual Enrollment : 305 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Suivi et Traitement du Traumatisme Des Membres en Cas d'Afflux Massif de blessés Dans Les Contextes Difficiles
Study Start Date : January 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Patient Satisfaction with Musculoskeletal functional recovery [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Employment status [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779011


Locations
Haiti
ALIMA
Port-au-Prince, Haiti
Sponsors and Collaborators
Alliance for International Medical Action
Lille Economie Management UMR CNRS 8157
National Research Agency, France
Investigators
Principal Investigator: Marie-Christine Delauche, MD Alliance for International Medical Action
More Information

Additional Information:
Responsible Party: Alliance for International Medical Action
ClinicalTrials.gov Identifier: NCT01779011     History of Changes
Other Study ID Numbers: SuTra² (Suivi et Traitement du
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Wounds and Injuries
Amputation, Traumatic