A study to compare Tumescent versus Conventional Dissection in raising flaps during Radical Modified Mastectomy

Comparison of Tumescent versus Conventional Dissection in raising flaps during Modified Radical Mastectomy - A Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096241

Enrollment

Registered

2025-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: C504- Malignant neoplasm of upper-outerquadrant of breast

Interventions

Intervention1: Tumescent mastectomy: injecting tumescent solution (mixture of saline, lignocaine, and adrenaline) before raising flaps in MRM total duration- 1 year (11 cases) Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 18-65 yrs women

Exclusion criteria

Exclusion criteria: prior breast surgery (except biopsy)/ recurrence immediate breast reconstruction previous radiotherapy allergy to lignocaine

Design outcomes

Primary

Measure	Time frame
Amount of blood loss (in ml)Timepoint: baseline and day-0	—

Secondary

Measure	Time frame
operative time (in mins)Timepoint: baseline;presence of any skin flap necrosisTimepoint: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days;DURATION OF HOSPITAL STAYTimepoint: NIL;POSTOPERATIVE PAINTimepoint: baseline, 1,2,3,4,5,6,7 days ;SURGICAL SITE INFECTION INCLUDIMG INCISIONAL DEHISECENCETimepoint: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14 days;SEROMA/HEMATOMA FORMATIONTimepoint: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days	—

Measure

Time frame

operative time (in mins)Timepoint: baseline;presence of any skin flap necrosisTimepoint: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days;DURATION OF HOSPITAL STAYTimepoint: NIL;POSTOPERATIVE PAINTimepoint: baseline, 1,2,3,4,5,6,7 days ;SURGICAL SITE INFECTION INCLUDIMG INCISIONAL DEHISECENCETimepoint: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14 days;SEROMA/HEMATOMA FORMATIONTimepoint: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days

—

Countries

India

Contacts

Public ContactAyushi Singla

Maulana Azad Medical College

ayushi.singla.07@gmail.com8447608543

Outcome results

None listed

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