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To compare the methods of stitching of skin and muscle to that of a medicated powder in reducing the fluid accumulation for those undergoing surgery for breast cancer

Quilting vs Microporous polysaccharide hemospheres (MPH) in reducing the volume of seroma formation after Modified radical mastectomy in patients with carcinoma breast - A single centre open label randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023929
Enrollment
76
Registered
2020-03-12
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: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Microporous Polysaccharide Hemospheres: Microporous polysaccharide hemospheres will be applied topically as a powder form, dispersed over the axillary and chest wall areas (about 5gm) j
each suture will incorporate the subcutaneous fat and the deep dermis on the edge of the flaps and the underlying muscle.

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient admitted in the Department of General Surgery for Modified Radical Mastectomy for Breast cancer

Exclusion criteria

Exclusion criteria: i.Patients with hypertension ii.Patients on anticoagulant therapy iii.BMI > 30 iv.Patients who underwent lumpectomy v.Patients undergoing bilateral modified radical mastectomy

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of Microporous polysaccharide hemospheres to that of Quilting in reducing the volume of seroma following MRM.Timepoint: 21 days—

Secondary

MeasureTime frame
i.Duration of hospital stay ii.Clinically significant seroma iii.Surgical site infection iv. Flap necrosis v. Wound breakdown vi. Duration of the procedure vii. Arm mobilisationTimepoint: 21 days—

Countries

India

Contacts

Public ContactMuhamed Tajudeen

JIPMER

tajudeen9495@gmail.com

Outcome results

None listed

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