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Use of single dose of antibiotic versus three dose of antibiotic to prevent infection in breast cancer surgery

EFFICACY OF SINGLE VERSUS THREE DOSE PROPHYLACTIC ANTIBIOTIC ON THE PREVENTION OF SURGICAL SITE INFECTION IN BREAST CANCER SURGERY - A RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028111
Enrollment
100
Registered
2020-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C50- Malignant neoplasm of breast

Interventions

Intervention1: Single dose Peri-operative antibiotic: Patients undergoing breast cancer surgery receiving single peri-operative intravenous injection of Amoxycillin (1gm) + Amoxycillin (200mg) at the

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with biopsy proven breast malignancy 2. Patients undergoing mastectomy or BCS without major reconstruction

Exclusion criteria

Exclusion criteria: 1. Ulcerated and infected breast lesions 2. Conditions requiring antibiotics pre-operatively 3. Conditions other than SSI requiring antibiotics in the post operative period 4. Patients undergoing oncoplastic volume replacement surgery and major reconstruction after breast surgery 5. Patients undergoing surgery in other organ along with breast cancer surgery 6. Those who are not giving consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Incidence of surgical site infection in control and intervention group and in high risk patients.Timepoint: Within 30 days of Surgery

Secondary

MeasureTime frame
Delay in starting adjuvant treatmentTimepoint: Delay more than 6 weeks after surgery;Organism causing surgical site infectionTimepoint: Development of surgical site infection

Countries

India

Contacts

Public ContactDipin KR

AIIMS, Bhubaneswar

dillipmuduly@gmail.com9013072969

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026