SuTra²: Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts
Sponsor
Alliance for International Medical Action (Other)
Overall Status
Completed
CT.gov ID
NCT01779011
Collaborator
Lille Economie Management UMR CNRS 8157 (Other), National Research Agency, France (Other)
305
1
16
19.1
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
:
Jan 1, 2011
Actual Primary Completion Date
:
May 1, 2012
Actual Study Completion Date
:
May 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
- Patient Satisfaction with Musculoskeletal functional recovery [2 years]
Secondary Outcome Measures
- Employment status [2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Alliance for International Medical Action
ClinicalTrials.gov Identifier:
NCT01779011
Other Study ID Numbers:
- SuTra² (Suivi et Traitement du
First Posted:
Jan 29, 2013
Last Update Posted:
Jan 29, 2013
Last Verified:
Jan 1, 2013