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RCT to evaluate effect of fibrin glue on seroma formation post MRM

Evaluation of the effect of fibrin glue sealant on drain output and seroma formation in patients undergoing Modified Radical Mastectomy for carcinoma breast

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025011
Enrollment
40
Registered
2020-05-04
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: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: Fibrin glue: 2ml of fibrin glue was sprayed in the axillary fossa after axillary dissection during modified radical mastectomy and compression given for 3 to 4 minutes before closure ov

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All women with biopsy proven carcinoma breast undergoing modified radical mastectomy

Exclusion criteria

Exclusion criteria: 1) Patients who received neoadjuvant chemoterapy or radiation to the breast/ axilla 2) Liver disease 3) History of coagulation disorder 4) Patients on anti coagulants 5) BMI > 35 kg/metre square

Design outcomes

Primary

MeasureTime frame
1. Incidence of seroma formation 2. Duration of drain in situ 3. Total drain output till the time of drain removalTimepoint: During hospital stay and at 1 week, 2 weeks and 4 weeks from day of surgery—

Secondary

MeasureTime frame
1. Duration of hospital stay 2. Surgical site infectionTimepoint: At 1 week, 2 weeks and 4 weeks from day of surgery—

Countries

India

Contacts

Public ContactShruti Sharma

Maulana Azad Medical College

drdeepakghuliani@hotmail.com9899326388

Outcome results

None listed

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