Penetrating Injury in Upper LimbPhase 2NCT01253863
Diagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries
A Phase 2 study testing exploration in people with Penetrating Injury in Upper Limb, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the accuracy of preoperative clinical examination in penetrating injuries Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Penetrating Injury in Upper Limb
- What is being tested?
- exploration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIran
- Study dates
- Aug 2006to Sep 2009
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Deep penetrating injury to upper limb
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Accuracy of Preoperative Examination in Penetrating Wound
The purpose of this study is to determine the accuracy of preoperative clinical examination in penetrating injuries
Read the detailed description
Penetrating injuries is a common cause of severe neurovascular damage, both in adults and children.we evaluated the accuracy of the preoperative clinical examination in depicting lesions caused by penetrating wounds of hands or forearms.
- Conditions
- Penetrating Injury in Upper Limb
- Being tested
- exploration
- Keywords
- Clinical Examination, Accuracy, Hand, Tendon, Injury.
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
explorationOther
exploration of wound for determining damaged tissue
| Study group | Role | What they receive |
|---|---|---|
| determining damaged tissue | Other | Not described Receives: Other: exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of determined tendon
we evalauted tendon injuries without exploration of wound
Measured: 5 min after admission
Secondary outcomes (2)
number of determined injured nerves
we evaluated the number of detemined injured nerves without exploration of wound
Measured: 5 min after admision
number of damaged arteries
we evaluated the number of detemined injured arteries without exploration of wound
Measured: 5 min after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startAug 2006
- Primary completionMay 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating Injury in Upper LimbStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamidreza shemshaki, MD, Study chair, research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253863
- Sponsor's protocol ID
- ASD-1213-7
- Status last verified
- Aug 2006
- First submitted
- 2 Dec 2010
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Accuracy of Preoperative Examination in Penetrating Wound
- ClinicalTrials.gov ID
- NCT01253863
- Acronym / sponsor ID
- ASD-1213-7
- Conditions
- Penetrating Injury in Upper Limb
- Keywords
- Clinical Examination, Accuracy, Hand, Tendon, Injury.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Dec 2010 (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 purpose of this study is to determine the accuracy of preoperative clinical examination in penetrating injuries
Detailed description
Penetrating injuries is a common cause of severe neurovascular damage, both in adults and children.we evaluated the accuracy of the preoperative clinical examination in depicting lesions caused by penetrating wounds of hands or forearms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| determining damaged tissue | Other | Other: exploration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Deep penetrating injury to upper limb
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| explorationexploration of wound for determining damaged tissue | Other | determining damaged tissue |
Primary outcome
number of determined tendon
Time frame: 5 min after admission
we evalauted tendon injuries without exploration of wound
2 secondary outcomes
number of determined injured nerves
Time frame: 5 min after admision
number of damaged arteries
Time frame: 5 min after admission
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 3 Dec 2010.
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.
hamidreza shemshaki, MD study chair
research comittee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exploration in people with Penetrating Injury in Upper Limb, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 3 Dec 2010. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of determined tendon (time frame: 5 min after admission). 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 3 Dec 2010.