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

This study has been completed.
Sponsor:
Collaborators:
Lille Economie Management UMR CNRS 8157
National Research Agency, France
Information provided by (Responsible Party):
Alliance for International Medical Action
ClinicalTrials.gov Identifier:
NCT01779011
First received: December 15, 2012
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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
Wounds and Injuries
Traumatic Amputation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alliance for International Medical Action:

Primary Outcome Measures:
  • Patient Satisfaction with Musculoskeletal functional recovery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Employment status [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Alliance for International Medical Action
ClinicalTrials.gov Identifier: NCT01779011     History of Changes
Other Study ID Numbers: SuTra² (Suivi et Traitement du
Study First Received: December 15, 2012
Last Updated: January 28, 2013
Health Authority: Haiti: Ministry of Public Health and Population

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014