Deep WoundNCT03038581
Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries
An observational study of Deep Wound and Wrist Injuries, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Wound, Wrist Injuries
- How many people
- 183 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with deep wrist injuries that were treated 2008-2018 in University Hospital Schleswig-Holstein
Who may be able to join
- Deep wrist injury from 2008-2018
- Treated in University Hospital Schleswig-Holstein
- Agreed to retrospective analysis, questionnaires and hand function assessment
Who cannot join
- Non-compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.
Read the detailed description
Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries involve risks that require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. Therefore, the investigators analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.
- Conditions
- Deep Wound, Wrist Injuries
- Keywords
- Deep wrist injury, Self inflicted, Traumatic wrist injury
- Medical subject headings
- Wrist Injuries
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 |
|---|---|---|
| Self-inflicted wrist injury | Wrist injury by self-infliction | |
| Traumatic wrist injury | Wrist injury by not self-inflicted trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand function
Assessment of hand function by measuring sensibility (2-point-discrimination) and motoric (degree joints)
Measured: Up to 10 years
Secondary outcomes (1)
Psychiatric history
Assessment of quality of life
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startOct 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep WoundStudies 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
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
- Investigators
- Tobias Kisch, MD, Principal investigator, University of Schleswig-Holstein, Campus Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038581
- Sponsor's protocol ID
- 13-054
- Other IDs
- U1111-1176-0115
- Status last verified
- Dec 2019
- First submitted
- 29 Oct 2015
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries
- ClinicalTrials.gov ID
- NCT03038581
- Acronym / sponsor ID
- 13-054
- Conditions
- Deep Wound, Wrist Injuries
- Keywords
- Deep wrist injury, Self inflicted, Traumatic wrist injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 31 Jan 2017 (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.
Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.
Detailed description
Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries involve risks that require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. Therefore, the investigators analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-inflicted wrist injury | – | –Wrist injury by self-infliction |
| Traumatic wrist injury | – | –Wrist injury by not self-inflicted trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with deep wrist injuries that were treated 2008-2018 in University Hospital Schleswig-Holstein
Key inclusion criteria (3 listed)
- Deep wrist injury from 2008-2018
- Treated in University Hospital Schleswig-Holstein
- Agreed to retrospective analysis, questionnaires and hand function assessment
Key exclusion criteria (1 listed)
- Non-compliance
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
Hand function
Time frame: Up to 10 years
Assessment of hand function by measuring sensibility (2-point-discrimination) and motoric (degree joints)
1 secondary outcome
Psychiatric history
Time frame: Up to 10 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 3 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Tobias Kisch, MD principal investigator
University of Schleswig-Holstein, Campus Lübeck, Germany
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 Deep Wound and Wrist Injuries, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 3 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 2019. 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 Germany. 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?
Hand function (time frame: Up to 10 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 3 Dec 2019.