Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402715350374 Date of Approval: 23/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Reduction of Septic Complications in High-Risk Compound Skull Fractures
Official scientific title Reduction of Septic Complications in High-Risk Compound Skull Fractures
Brief summary describing the background and objectives of the trial Patients with compound skull fractures are at risk of developing septic complications such as superficial wound sepsis, meningitis, osteomyelitis and rarely sub-dural and extradural empyema.1–4 These complications prolong the length of stay in hospital and result in increased morbidity and mortality.5–8 Risk factors which contribute to septic complications have been identified, yet their role both individually and collectively in sepsis risk have not been quantified, particularly related to the mechanism of injury and the time to definitive management. These risk factors currently anecdotally guide surgical management9, with the role of antibiotics poorly defined and delineated. The use of prophylactic antibiotics and antibiotic treatment could significantly alter the risk of developing septic complications in compound skull fractures. The primary objective of this study is to determine if administering pre-emptive antibiotic treatment to patients with high risk for developing septic complications from compound skull fractures reduces the incidence of septic complications.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2024
Actual trial start date 01/05/2024
Anticipated date of last follow up 30/04/2025
Actual Last follow-up date 14/06/2025
Anticipated target sample size (number of participants) 116
Actual target sample size (number of participants) 116
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Administering Pre emptive Antibiotic tretament Cefazolin 2g Intravenous infusion 8 hourly for Gentamycin 5mg/kg daily for 5 days Antibiotic administration to patients with compound skull fractures 116
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adults (age 18 and above) presenting with compound skull vault fractures who have: 1. Received primary wound care within 12 hours of injury. 2. Receive definitive surgery within 72 hours of injury. 3. Received a single dose of 2g Cefazolin intravenously within 12 hours of injury and have any one of the following risk factors for septic complications: - air sinus involvement - or clinical or radiological evidence of wound contamination Children under the age of 18. Gunshot injuries. Septic complication at time of presentation. Compound skull fractures with no high-risk features. Patients suffering from base of skull fractures only. Closed skull fractures. Known antibiotic allergy. Patients known with severe comorbidities such as end stage renal disease, heart failure, liver failure. Adult: 19 Year-44 Year 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/02/2024 PhD Review Commitee Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Avenue Parow 7050 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome A Reduction in the incidence of septic complications to 3 percent. All patients successfully recruited will be reviewed during in patient stay daily and at 6 weeks after inclusion for signs of septic complications
Secondary Outcome Neurological outcomes at 6 weeks post treatment follow will be assessed 6 weeks after completion of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Francie Van Zijl Avenue Parow 7050 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Division of Neurosurgery Stellenbosch University Francie van Zijl Avenue Parow 7050 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None N/A NA N/A South Africa Not applicable
COLLABORATORS
Name Street address City Postal code Country
Prof AJ Vlok Francie Van Zijl Avenue Parow 7050 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ruan Grobler ruan212@gmail.com +27846457240 Francie Van Zijl Avenue
City Postal code Country Position/Affiliation
Parow 7050 South Africa PhD Student Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Ruan Grobler ruan212@gmail.com +27846457240 Francie Van Zijl Avenue
City Postal code Country Position/Affiliation
Parow 7050 South Africa PhD Student Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Ruan Grobler ruan212@gmail.com +27846457240 Francie van Zijl Avenue
City Postal code Country Position/Affiliation
Parow 7050 South Africa PhD Student Stellenbosch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data after de-identification will be available. Study protocol and statistical analysis plan will be available Statistical Analysis Plan,Study Protocol Data will be available immediately following publication Researchers at established institutions with sound research methodology will be granted access to data required for inclusion in meta-analysis with additional permission from Stellenbosch University Health Research Ethics committee required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information