Reconstructive SurgeryNCT06935916
Retrospective Analysis of Surgical Outcomes in Patients Treated for Gunshot-Related Bone Defects at Mekelle University Hospital
An observational study of Reconstructive Surgery, run by Julian Joestl at 1 site in Austria.
Trial summary
his project looks back at past surgeries performed between 2019 and 2023 in a hospital in Mekelle, Ethiopia. During this time, a team of doctors from Austria and other countries visited the hospital to help patients who had been badly injured by gunshots, especially in the legs and arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reconstructive Surgery
- What is being tested?
- pedicled or free tissue transfer
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2019to 31 Dec 2023
- 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: All patients who underwent pedicled or free tissue transfer during the study period
Who may be able to join
- All patients who underwent pedicled or free tissue transfer during the study period
Who cannot join
- All other patients
Trial locations and contacts
1 site in 1 country.
About this study
his project looks back at past surgeries performed between 2019 and 2023 in a hospital in Mekelle, Ethiopia. During this time, a team of doctors from Austria and other countries visited the hospital to help patients who had been badly injured by gunshots, especially in the legs and arms. These injuries were very serious and often needed complex operations.
Why is this important? Mekelle is in a region that was affected by conflict and war. Hospitals there have very limited resources - not enough electricity, medical tools, or staff. The patients are often young people with injuries that would be easier to treat in better-equipped hospitals. This project wants to understand how the surgeries went under these difficult conditions and what could be done better in the future.
Read more
What will the doctors do in this study? They will look at hospital records from about 74 patients who had these surgeries. The doctors will not contact patients or do any new treatments. They are only using data that was already collected during treatment. The names and personal details of patients will not be used - everything will be anonymous.
The doctors will study:
The age and gender of patients What type of surgery was done How long surgeries lasted and whether electricity was available What happened after surgery - for example, whether the wound healed well or if there were problems What is the goal? The goal is to learn what worked well and what didn't - and to use this knowledge to plan future humanitarian missions. The results could also help improve care for people in similar situations in other parts of the world.
Are there any risks? No. This is a purely retrospective study. That means it only looks at past data. There will be no contact with patients, and no further action taken based on the study. All personal information will be protected according to strict privacy rules.
Who is behind this project? The project is led by Dr. Viktoria Koenig, a plastic surgeon from Austria who took part in the missions and has experience with this kind of surgery.
Why is this relevant? This study will help medical teams better prepare for working in difficult environments. It will also show how surgery can still help people even when resources are very limited - and highlight the importance of teamwork, planning, and flexible medical approaches.
- Conditions
- Reconstructive Surgery
- Being tested
- pedicled or free tissue transfer
- Keywords
- free fibula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedicled or free tissue transferProcedure or surgery
pedicled or free tissue transfer
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent pedicled or free tissue transfer | patients who underwent pedicled or free tissue transfer Receives: Procedure: pedicled or free tissue transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of the transferred tissue
Survival rate of the transferred tissue
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reconstructive SurgeryStudies 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
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julian Joestl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935916
- Sponsor's protocol ID
- GSR/0832/10
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gufue ZH, Haftu HK, Alemayehu Y, Tsegay EW, Mengesha MB, Dessalegn B. Damage to the public health system caused by war-related looting or vandalism in the Tigray region of Northern Ethiopia. Front Public Health. 2024 Apr 5;12:1271028. doi: 10.3389/fpubh.2024.1271028. eCollection 2024.
PubMed 38645448
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Surgical Outcomes in Patients Treated for Gunshot-Related Bone Defects at Mekelle University Hospital
- ClinicalTrials.gov ID
- NCT06935916
- Acronym / sponsor ID
- GSR/0832/10
- Conditions
- Reconstructive Surgery
- Keywords
- free fibula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Julian JoestlUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Apr 2025 (actual)
- 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.
his project looks back at past surgeries performed between 2019 and 2023 in a hospital in Mekelle, Ethiopia. During this time, a team of doctors from Austria and other countries visited the hospital to help patients who had been badly injured by gunshots, especially in the legs and arms. These injuries were very serious and often needed complex operations.
Why is this important? Mekelle is in a region that was affected by conflict and war. Hospitals there have very limited resources - not enough electricity, medical tools, or staff. The patients are often young people with injuries that would be easier to treat in better-equipped hospitals. This project wants to understand how the surgeries went under these difficult conditions and what could be done better in the future.
What will the doctors do in this study? They will look at hospital records from about 74 patients who had these surgeries. The doctors will not contact patients or do any new treatments. They are only using data that was already collected during treatment. The names and personal details of patients will not be used - everything will be anonymous.
The doctors will study:
The age and gender of patients What type of surgery was done How long surgeries lasted and whether electricity was available What happened after surgery - for example, whether the wound healed well or if there were problems What is the goal? The goal is to learn what worked well and what didn't - and to use this knowledge to plan future humanitarian missions. The results could also help improve care for people in similar situations in other parts of the world.
Are there any risks? No. This is a purely retrospective study. That means it only looks at past data. There will be no contact with patients, and no further action taken based on the study. All personal information will be protected according to strict privacy rules.
Who is behind this project? The project is led by Dr. Viktoria Koenig, a plastic surgeon from Austria who took part in the missions and has experience with this kind of surgery.
Why is this relevant? This study will help medical teams better prepare for working in difficult environments. It will also show how surgery can still help people even when resources are very limited - and highlight the importance of teamwork, planning, and flexible medical approaches.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent pedicled or free tissue transfer | – | Procedure: pedicled or free tissue transferpatients who underwent pedicled or free tissue transfer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent pedicled or free tissue transfer during the study period
Key inclusion criteria (1 listed)
- All patients who underwent pedicled or free tissue transfer during the study period
Key exclusion criteria (1 listed)
- All other patients
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 |
|---|---|---|
| pedicled or free tissue transferpedicled or free tissue transfer | Procedure or surgery | patients who underwent pedicled or free tissue transfer |
Primary outcome
Survival rate of the transferred tissue
Time frame: Perioperative/Periprocedural
Survival rate of the transferred tissue
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 20 Apr 2025.
- Background: PubMed 38645448Gufue ZH, Haftu HK, Alemayehu Y, Tsegay EW, Mengesha MB, Dessalegn B. Damage to the public health system caused by war-related looting or vandalism in the Tigray region of Northern Ethiopia. Front Public Health. 2024 Apr 5;12:1271028. doi: 10.3389/fpubh.2024.1271028. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Reconstructive Surgery, run by Julian Joestl at 1 site in Austria.
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 20 Apr 2025. 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 Austria. 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?
Survival rate of the transferred tissue (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06935916, which also lists 1 linked publication.
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 20 Apr 2025.