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A RANDOMIZED CONTROL TRIAL TO FIND OUT THE INCIDENCE OF SURGICAL SITE INFECTIONS IN PATIENTS RECEIVING REDUCED DOSES OF STEROID AS PRE-MEDICATION IN PATIENTS RECEIVING NEO-ADJUVANT CHEMOTHERAPY FOR BREAST CANCER

INCIDENCE OF SURGICAL SITE INFECTIONS AFTER STEROID DOSE REDUCTION IN PATIENTS UNDERGOING NEOADJUVANT CHEMOTHERAPY FOR CARCINOMA BREAST:A NON-INFERIORITY RANDOMIZED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071498
Enrollment
80
Registered
2024-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: REDUCED DOSE OF DEXAMETHASONE GIVEN AS PRE-MEDICATION: These patients will be given single dose of 4mg dexamethasone IV bolus along with Adriamycin(60mg/m2) or cyclophospide(600mg/m2) f

Sponsors

Post Graduate Institute of Medical Education and Research,Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with biopsy proven breast carcinoma 2. All female patients falling under age group of 18-70 3. Patients willing to provide valid written consent

Exclusion criteria

Exclusion criteria: 1.Those who already received chemotherapy. 2.Recurrence patients and those who received palliative chemotherapy. 3.Patients with cardiac comorbidities. 4.Pregnant patients. 5.Patients on steroids for other systemic diseases. 6.ASA grade III & IV. 7.Cushing’s syndrome.

Design outcomes

Primary

MeasureTime frame
POST SURGERY PATIENT WILL BE FOLLOWED FOR 4-WEEKS FOR POST OPERATIVE SSIs & RE-ADMISSION FOR WOUND RELATED COMPLICATIONSTimepoint: 4-WEEKS POST-OP,or TILL THE DATE OF REMOVAL OF DRAIN—

Secondary

MeasureTime frame
1.hypersensitivity 2.weight gain 3.endocrine profileTimepoint: 30 days post operative—

Countries

India

Contacts

Public ContactDr Anmol Singh

Postgraduate Institute of Medical Education and Research,Chandigarh

sakaraypgi@gmail.com7569838589

Outcome results

None listed

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