Antibiotic prophylaxis for uncomplicated herniorrhaphy without mesh in a resource-limited setting: a non-inferiority randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202511774848151

Enrollment

285

Registered

2025-11-24

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Surgical site infection Surgery

Interventions

Placebo

Cefazolin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years and < 65 years. 2. Diagnosis of uncomplicated unilateral inguinal hernia 3. Elective herniorrhaphy without mesh

Exclusion criteria

Exclusion criteria: 1. Recurrent hernia 2. Previously enrolled in study 3. Complicated hernia (e.g., strangulation) 4. Patients on corticosteroids or chemotherapy 5. Diabetes mellitus 6. HIV positive 7. Presence of infection at the time of surgery 8. Allergy to cefazolin 9. Taking antibiotics within 1 week of surgery 10. Pregnant or breastfeeding 11. Unwilling or unable to return (or connect by telephone) for follow-up after 30 days 12. Valvular heart disease

Design outcomes

Primary

Measure	Time frame
One or more episodes of surgical site infection (SSI) in the 30 days after surgery will be the primary endpoint. We will use the 2017 US Centre for Disease Control (CDC) definition of SSI.	—

Secondary

Measure	Time frame
Other post-operative complications: • moderate or severe pain at the time of discharge; • Unable to ambulate 24 hours post-op; • Unable to eat or drink 24 hours post-op; • Blood loss requiring transfusion; • Hematoma or seroma at surgical site (without infection), • Scrotal swelling, • Ileus, • Bowel perforation, • Dehiscence without infection, • Hernia recurrence, • Urinary retention, • Other post-operative complication determined by the surgeon or health care provider to be significant;Post-operative length of hospital stay, This will be defined as the number of days a patient will stay at a facility after herniorrhaphy (day 0 is counted as the day of the surgery).;Antibiotic use within 30 days of surgery. The type, dose, frequency, route and duration of all antibiotics will be recorded.;Nested cost-effectiveness study. The costs of antibiotic prophylaxis (single dose of cefazolin) will be tabulated. The cost of SSI, including costs related to prolonged hospitalization, costs of antibiotic treatment, costs of procedures and materials for drainage of the wound, will be tabulated. The patient’s hospital bill will be recorded such that a summary of costs can be compared in each treatment group. These data will allow a cost-effectiveness comparison of two scenarios (direct costs only): (1) no SAP and treatment of SSIs that arise; versus (2) SAP and treatment of possibly reduced SSI incidence.	—

Measure

Time frame

Other post-operative complications: • moderate or severe pain at the time of discharge; • Unable to ambulate 24 hours post-op; • Unable to eat or drink 24 hours post-op; • Blood loss requiring transfusion; • Hematoma or seroma at surgical site (without infection), • Scrotal swelling, • Ileus, • Bowel perforation, • Dehiscence without infection, • Hernia recurrence, • Urinary retention, • Other post-operative complication determined by the surgeon or health care provider to be significant;Post-operative length of hospital stay, This will be defined as the number of days a patient will stay at a facility after herniorrhaphy (day 0 is counted as the day of the surgery).;Antibiotic use within 30 days of surgery. The type, dose, frequency, route and duration of all antibiotics will be recorded.;Nested cost-effectiveness study. The costs of antibiotic prophylaxis (single dose of cefazolin) will be tabulated. The cost of SSI, including costs related to prolonged hospitalization, costs of antibiotic treatment, costs of procedures and materials for drainage of the wound, will be tabulated. The patient’s hospital bill will be recorded such that a summary of costs can be compared in each treatment group. These data will allow a cost-effectiveness comparison of two scenarios (direct costs only): (1) no SAP and treatment of SSIs that arise; versus (2) SAP and treatment of possibly reduced SSI incidence.

—

Countries

Democratic Republic of the Congo

Contacts

Public ContactKasereka Masumbuko Claude

Dean School of Medicine

kasereka@ualberta.ca+243825761414

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026