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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014