CTRI/2025/02/080791Not yet recruitingPhase 1
Effectiveness of incisional negative pressure wound therapy to reduce serous drainage following modified radical mastectomy in breast cancer patients: A randomised controlled trial.
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- AIIMS Jodhpur
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Reduction in serous discharge after MRM.
Study Overview
Brief Summary
This study is designed to compare effectiveness of incisional negative pressure wound therapy to reduce postoperative seroma in the patients undergoing modified radical mastectomy for breast cancer. If statistically significant results are found, then application of incisional negative pressure wound therapy might be used as standard procedure to reduce postoperative complications of modified radical mastectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All female patients with the diagnosis of breast cancer planned for Modified Radical Mastectomy (MRM) in the Department of General Surgery and Department of Surgical Oncology at All India Institute of Medical Sciences, Jodhpur.
Exclusion Criteria
- •Patients planned for breast reconstructive surgery Patients on Anticoagulants (Acitrom, Warfarin, Dabigatran) Patients on chemotherapy for non-breast malignancy Patients with diagnosis of unstable medical diseases (cardiac diseases, liver diseases, kidney diseases).
Outcomes
Primary Outcomes
Reduction in serous discharge after MRM.
Time Frame: POD1,2,3,7,10
Secondary Outcomes
- Reduction in flap necrosis, wound infection, wound dehicence.(4 weeks, 8 weeks)
Investigators
Dr Sanket Kevadiya
AIIMS Jodhpur
Study Sites (1)
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