The efficacy of an antibiotic-impregnated shunt system in sub-Saharan Africa

The efficacy of an antibiotic-impregnated shunt system in sub-Saharan Africa: a Randomized Controlled Trial of the Bactiseal Universal Shunt vs. the Chhabra Shunt in Uganda

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201804003240177

Enrollment

160

Registered

2018-03-22

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous System Diseases Paediatrics Hydrocephalus

Interventions

Standard Chhabra Shunt

Antibiotic-Impregnated Bactiseal Shunt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - less than 16 years old, - diagnosis of hydrocephalus of any etiology requiring a shunt - were afebrile 24 hours before surgery. - admission white blood cell count (WBC) <11,000cell/mm3, - admission cerebral spinal fluid (CSF) cell count <5cells/mm3 - admission negative CSF Gram stain and culture within 24 hours prior to surgery.

Exclusion criteria

Exclusion criteria: - hydrocephalus patients previously treated with a shunt - patients with closed fontanelles - patients with absent frontal lobes

Design outcomes

Primary

Measure	Time frame
Shunt Infection	—

Secondary

Measure	Time frame
Shunt malfunction;Re-operation	—

Countries

Uganda

Contacts

Public ContactEdith Mbabazi

Research Coordinator

edithmbabazi@gmail.com256-0-454-435273

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026