Wounds and InjuriesSuTra²NCT01779011
Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts
An observational study of Wounds and Injuries and Traumatic Amputation, run by Alliance for International Medical Action at 1 site in Haiti.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries, Traumatic Amputation
- How many people
- 305 participants
- Where
- 1 siteHaiti
- Study dates
- Jan 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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)
Who may be able to join
- Patients, with limb injuries due to the earthquake,
- Who underwent limb surgery, which ended up in limb amputation or limb conservation.
Who cannot join
- Limb injury not related to the earthquake
- No surgery for the limb injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suivi et Traitement du Traumatisme Des Membres en Cas d'Afflux Massif de blessés Dans Les Contextes Difficiles
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.
- Conditions
- Wounds and Injuries, Traumatic Amputation
- Medical subject headings
- Wounds and Injuries, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction with Musculoskeletal functional recovery
Measured: 2 years
Secondary outcomes (1)
Employment status
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Lille Economie Management UMR CNRS 8157, National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Marie-Christine Delauche, MD, Principal investigator, Alliance for International Medical Action
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779011
- Sponsor's protocol ID
- SuTra² (Suivi et Traitement du
- Acronym
- SuTra²
- Status last verified
- Jan 2013
- First submitted
- 15 Dec 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suivi et Traitement du Traumatisme Des Membres en Cas d'Afflux Massif de blessés Dans Les Contextes Difficiles
- ClinicalTrials.gov ID
- NCT01779011
- Acronym / sponsor ID
- SuTra² / SuTra² (Suivi et Traitement du
- Conditions
- Wounds and Injuries, Traumatic Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Lille Economie Management UMR CNRS 8157, National Research Agency, France
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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)
Key inclusion criteria (2 listed)
- Patients, with limb injuries due to the earthquake,
- Who underwent limb surgery, which ended up in limb amputation or limb conservation.
Key exclusion criteria (2 listed)
- Limb injury not related to the earthquake
- No surgery for the limb injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Satisfaction with Musculoskeletal functional recovery
Time frame: 2 years
1 secondary outcome
Employment status
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Christine Delauche, MD principal investigator
Alliance for International Medical Action
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and Traumatic Amputation, run by Alliance for International Medical Action at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction with Musculoskeletal functional recovery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.