NCT06879028

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 11, 2025

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rates of Surgical Sites infection

    6 months

  • Cosmosis and Post Op Appearance

    6 months

Study Arms (1)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient of both sexes admitted to Trauma unit.

You may qualify if:

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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, Asyut Governorate, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Islam Mostafa AbdelBary Ebrahim

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations