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To reduce Swelling after breast surgery

A three arm randomized control trial to study the efficacy of flap fixation with sutures and conventional closure plus intravenous octreotide in comparison with conventional skin closure in the reduction of post mastectomy seroma formation"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054062
Enrollment
90
Registered
2023-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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 Health Condition 2: O- Medical and Surgical Health Condition 3: O- Medical and Surgical

Interventions

Intervention1: intervention group: Flap fixation in Modified radical mastectomy using sutures Intervention2: intervention group: Systemic administration of Octreotide during post operative period of

Sponsors

SRM Institute of science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of all age groups with radiologically diagnosed & pathologically proven carcinoma breast planned for modified radical mastectomy Stage 2 and stage 3 carcinoma breast Patients who were fit for general anaesthesia Patients who consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients who had undergone neoadjuvant chemotherapy Patients who had undergone previous ipsilateral breast surgery Patients who undergoes breast conservative surgery Stage 1 and Stage 4 carcinoma breast Patients having bleeding diathesis / uncontrolled diabetes mellitus / uncontrolled hypertension Patients who are severely obese BMI more than 40 Patients who had previous surgery in axillary lymphatic system Patients who do not consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Amount of fluid drainageTimepoint: 24hrs,36hrs and 48hrs

Secondary

MeasureTime frame
Wound infection Hospital stayTimepoint: 24hrs,36hrs,48hrs and 1 week

Countries

India

Contacts

Public ContactAthira Gopinathan

SRM Institute of science and Technology

balamurr@srmist.edu.in9841434506

Outcome results

None listed

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