1. Randomized Controlled Clinical Trial for Mastectomy Skin Flaps: Pre-Mammary Fascial Plane Versus a Thin Skin Flap Between Small and Large Fat Lobules and Flap Raised by Scalpel Versus Electrodiathermy.
- Author
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Patel, Swapnil, Kataria, Kamal, Ranjan, Piyush, Dhar, Anita, Seenu, Vuthaluru, Pandey, Ravindra Mohan, and Srivastava, Anurag
- Subjects
RISK assessment ,RESEARCH funding ,HUMAN beings ,STATISTICAL sampling ,NECROSIS ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,TREATMENT effectiveness ,SURGICAL flaps ,ELECTROCOAGULATION (Medicine) ,SURGICAL complications ,FASCIAE (Anatomy) ,MASTECTOMY ,SURGICAL site infections ,SURGICAL instruments ,COMPARATIVE studies ,BREAST ,DISEASE risk factors - Abstract
Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]
- Published
- 2024
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