A RANDOMISED CONTROL STUDY COMPARING THE PLACEMENT OF 2 DRAINS, THAT IS, IN AXILLA AND PECTORAL SKIN FLAP VERSUS SINGLE DRAIN IN AXILLA POST MODIFIED RADICAL MASTECTOMY IN PREVENTING POST OPERATIVE SEROMA AND LOCAL COMPLOCATIONS

A prospective randomized controlled study to compare the efficacy of combined Axillary and Pectoral drainage versus Sole Axillary drainage in Modified Radical Mastectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049897

Enrollment

156

Registered

2023-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: C50-C50- Malignant neoplasms of breast

Interventions

Intervention1: SINGLE AXILLARY DRAIN: SINGLE ROMOVAC SUCTION DRAIN NO 14 PLACED IN AXILLA FREQUENCY NOT APPLICABLE DURATION- PATIENT DEPENDANT Control Intervention1: COMBINED AXILLARY AND PECTORAL DRA

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven Breast cancer patients of Stage 1 and II undergoing Modified Radical Mastectomy Stage III breast cancer not receiving neo-adjuvant treatment undergoing Modified Radical Mastectomy

Exclusion criteria

Exclusion criteria: Recurrent breast cancer Patients receiving Neoadjuvant chemotherapy or Radiotherapy Metastatic breast cancer

Design outcomes

Primary

Measure	Time frame
To assess occurrence of post-operative seroma with use of single versus double drainage in modified radical mastectomy, in patients with histologically proven breast cancer not undergoing neoadjuvant therapyTimepoint: 1ST, 3RD, 5TH, 7TH, 9TH DAY POST OPERATIVELY	—

Secondary

Measure	Time frame
Post-operative pain Occurrence of Flap necrosis Duration of drain in-situ Drain output Length of hospital stay Timepoint: 3RD, 6TH, 9TH DAY POST OPERATIVELY	—

Countries

India

Contacts

Public ContactDR DEEPALI SHETTY

AIIMS, NAGPUR

djshetty97@gmail.com9008811623

Outcome results

None listed

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