Head Trauma InjuryNCT06879028
The Outcome of Various Methods of Surgical Reconstruction of Depressed Skull Fractures
An observational study of Head Trauma Injury, run by Assiut University at 1 site in Egypt.
Trial summary
To investigate the outcomes of different approaches to surgical repair/Elevation of Traumatic Depressed Skull Fractures To improve the outcome of surgical elevation of depressed fractures regarding the rate of post-operative deficit and complications, as well as the aesthetics and patient recovery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head Trauma Injury
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Oct 2024
- 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: Any patient of both sexes admitted to Trauma unit.
- Inclusion criteria:
- Any patient of both sexes admitted to Trauma unit with total coverage of 1 year.
- Patients with Surgically indicated Depressed Skull Fractures
- Exclusion criteria:
- Patients with congenital causes of depressed fractures 2. Patients with Old trauma (1 month or more). 3. Patients with Severe Polytrauma, and no evident Neurosurgical emergency. 3. Patients that need ICU/ CCU admission. 4. Patients with Expressed Fractures.
Trial locations and contacts
1 site in 1 country.
About this study
- To investigate the outcomes of different approaches to surgical repair/Elevation of Traumatic Depressed Skull Fractures
- To improve the outcome of surgical elevation of depressed fractures regarding the rate of post-operative deficit and complications, as well as the aesthetics and patient recovery
Read the detailed description
Depressed Fractures are of the commonest conditions seen in Head injuries; its incidence is unknown, but it is seen most commonly in Assault by hard objects and Road Traffic Accidents (8) and other high momentum collisions with the skull. Parietal bone is the most commonly fractured, followed by Temporal, Occipital and Frontal bones (1,8) They are classified mainly as Simple (Closed) or Compound (Open). Depressed fractures can be managed conservatively (2,3) but surgical intervention is needed if the depression is greater than calvarium thickness (1,2,8) or the fracture is over the Superior Sagittal Sinus, or risk infection from external debris. (4,6) Depressed Fractures when associated with underlying intracranial pathology (Mostly Haematoma or contusions) (1,2,8) require surgical elevation and management of other complications.
Elevation and debridement is recommended as the surgical method of choice. All management strategies for compound depressed fractures should include antibiotics. (1,2,8) Paediatric populations have better outcome (3,7) due to possibility for future remodelling and cranial growth.
Safe and effective surgical techniques to elevate Depressed fractures include craniotomy, surgical elevation with primary replacement of bone fragments in place, elevation through a burr hole at the periphery, fixation of bone fragments with miniplates, or fixation of bone fragments with vicryl sutures.
However, no available studies signify a preferable approach to depressed fractures or outcome of different methods. So, our study will try to identify and establish a significant treatment plan and preferable approach.
- Golfinos JG, Cooper PR. Skull fracture and post-traumatic cerebrospinal fluid fistula. In: Head Injury, 4th, Cooper PR, Golfinos JG (Eds), McGraw-Hill, New York 2000. p.155.
- Bullock, M. R., Chesnut, R., Ghajar, J., Gordon, D., Hartl, R., Newell, D. W., … Wilberger, J. (2006). Surgical Management of Depressed Cranial Fractures. Neurosurgery, 58(Supplement), S2-56-S2-60. doi:10.1227/01.neu.0000210367.14
- Bonfield, C. M., Naran, S., Adetayo, O. A., Pollack, I. F., \& Losee, J. E. (2014). Pediatric skull fractures: the need for surgical intervention, characteristics, complications, and outcomes. Journal of Neurosurgery: Pediatrics, 14(2), 205-211. doi:10.3171/2014.5.peds13414
- HESHAM EL-SOBKEY, M.D., Ph.D., A. F. K. M. P. Surgical Elevation for Symptomatic Depressed Skull Fractures Over Dural Venous Sinus. The Medical Journal of Cairo University, 2019; 87(June): 1917-1925. doi: 10.21608/mjcu.2019.54048
- Nnadi MO, Bankole OB, Arigbabu SO. Outcome of surgically treated non-missile traumatic depressed skull fracture. Niger Postgrad Med J. 2014 Dec;21(4):311-4. PMID: 25633449.
- Abdelaal, M., Saro, A., Fadl, K., Abdelrahman, A. Management of Compound Depressed Fractures Over Major Cranial Venous Sinuses. The Egyptian Journal of Hospital Medicine, 2021; 83(1): 1177-1182. doi: 10.21608/ejhm.2021.161776
- Al-Haddad SA, Kirollos R. A 5-year study of the outcome of surgically treated depressed skull fractures. Ann R Coll Surg Engl. 2002 May;84(3):196-200. PMID: 12092875; PMCID: PMC2503833.
- Prakash A, Harsh V, Gupta U, Kumar J, Kumar A. Depressed Fractures of Skull: An Institutional Series of 453 Patients and Brief Review of Literature. Asian J Neurosurg. 2018 Apr-Jun;13(2):222-226. doi: 10.4103/ajns.AJNS_168_16. PMID: 29682012; PMCID: PMC5898083.
- Conditions
- Head Trauma Injury
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 |
|---|---|---|
| Cases presented with Depressed Fractures needing surgical intervention at Assiut University Hosppita | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Surgical Sites infection
Measured: 6 months
Cosmosis and Post Op Appearance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879028
- Sponsor's protocol ID
- CDAUHNS
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Various Methods of Surgical Reconstruction of Depressed Skull Fractures
- ClinicalTrials.gov ID
- NCT06879028
- Acronym / sponsor ID
- CDAUHNS
- Conditions
- Head Trauma Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 17 Mar 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.
- To investigate the outcomes of different approaches to surgical repair/Elevation of Traumatic Depressed Skull Fractures
- To improve the outcome of surgical elevation of depressed fractures regarding the rate of post-operative deficit and complications, as well as the aesthetics and patient recovery
Detailed description
Depressed Fractures are of the commonest conditions seen in Head injuries; its incidence is unknown, but it is seen most commonly in Assault by hard objects and Road Traffic Accidents (8) and other high momentum collisions with the skull. Parietal bone is the most commonly fractured, followed by Temporal, Occipital and Frontal bones (1,8) They are classified mainly as Simple (Closed) or Compound (Open). Depressed fractures can be managed conservatively (2,3) but surgical intervention is needed if the depression is greater than calvarium thickness (1,2,8) or the fracture is over the Superior Sagittal Sinus, or risk infection from external debris. (4,6) Depressed Fractures when associated with underlying intracranial pathology (Mostly Haematoma or contusions) (1,2,8) require surgical elevation and management of other complications.
Elevation and debridement is recommended as the surgical method of choice. All management strategies for compound depressed fractures should include antibiotics. (1,2,8) Paediatric populations have better outcome (3,7) due to possibility for future remodelling and cranial growth.
Safe and effective surgical techniques to elevate Depressed fractures include craniotomy, surgical elevation with primary replacement of bone fragments in place, elevation through a burr hole at the periphery, fixation of bone fragments with miniplates, or fixation of bone fragments with vicryl sutures.
However, no available studies signify a preferable approach to depressed fractures or outcome of different methods. So, our study will try to identify and establish a significant treatment plan and preferable approach.
- Golfinos JG, Cooper PR. Skull fracture and post-traumatic cerebrospinal fluid fistula. In: Head Injury, 4th, Cooper PR, Golfinos JG (Eds), McGraw-Hill, New York 2000. p.155.
- Bullock, M. R., Chesnut, R., Ghajar, J., Gordon, D., Hartl, R., Newell, D. W., … Wilberger, J. (2006). Surgical Management of Depressed Cranial Fractures. Neurosurgery, 58(Supplement), S2-56-S2-60. doi:10.1227/01.neu.0000210367.14
- Bonfield, C. M., Naran, S., Adetayo, O. A., Pollack, I. F., \& Losee, J. E. (2014). Pediatric skull fractures: the need for surgical intervention, characteristics, complications, and outcomes. Journal of Neurosurgery: Pediatrics, 14(2), 205-211. doi:10.3171/2014.5.peds13414
- HESHAM EL-SOBKEY, M.D., Ph.D., A. F. K. M. P. Surgical Elevation for Symptomatic Depressed Skull Fractures Over Dural Venous Sinus. The Medical Journal of Cairo University, 2019; 87(June): 1917-1925. doi: 10.21608/mjcu.2019.54048
- Nnadi MO, Bankole OB, Arigbabu SO. Outcome of surgically treated non-missile traumatic depressed skull fracture. Niger Postgrad Med J. 2014 Dec;21(4):311-4. PMID: 25633449.
- Abdelaal, M., Saro, A., Fadl, K., Abdelrahman, A. Management of Compound Depressed Fractures Over Major Cranial Venous Sinuses. The Egyptian Journal of Hospital Medicine, 2021; 83(1): 1177-1182. doi: 10.21608/ejhm.2021.161776
- Al-Haddad SA, Kirollos R. A 5-year study of the outcome of surgically treated depressed skull fractures. Ann R Coll Surg Engl. 2002 May;84(3):196-200. PMID: 12092875; PMCID: PMC2503833.
- Prakash A, Harsh V, Gupta U, Kumar J, Kumar A. Depressed Fractures of Skull: An Institutional Series of 453 Patients and Brief Review of Literature. Asian J Neurosurg. 2018 Apr-Jun;13(2):222-226. doi: 10.4103/ajns.AJNS_168_16. PMID: 29682012; PMCID: PMC5898083.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases presented with Depressed Fractures needing surgical intervention at Assiut University Hosppita | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient of both sexes admitted to Trauma unit.
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
Rates of Surgical Sites infection
Time frame: 6 months
Cosmosis and Post Op Appearance
Time frame: 6 months
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 17 Mar 2025.
- Individual participant dataSharing planned: Yes
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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 Head Trauma Injury, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 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 Egypt. 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?
Rates of Surgical Sites infection (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Mar 2025.