The Outcome of Various Methods of Surgical Reconstruction of Depressed Skull Fractures

• 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

Study Overview

• Status: Completed
• Conditions: Head Trauma Injury

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.

1. 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.
2. 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
3. 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
4. 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
5. 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.
6. 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
7. 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.
8. 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient of both sexes admitted to Trauma unit.

Description

1. Inclusion criteria:

   1. Any patient of both sexes admitted to Trauma unit with total coverage of 1 year.
   2. Patients with Surgically indicated Depressed Skull Fractures

2. Exclusion criteria:

   1. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cases presented with Depressed Fractures needing surgical intervention at Assiut University Hosppita

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rates of Surgical Sites infection	6 months
Cosmosis and Post Op Appearance	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Trauma, Nervous System; Craniocerebral Trauma; Skull Fractures; Skull Fracture, Depressed
• Other Study ID Numbers: CDAUHNS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No