RecruitingNot ApplicableNCT06024187

Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial

Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective Randomized Controlled Trial

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

566 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

Summary

The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery. The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques used during nipple-sparing mastectomy — a surgery that removes breast tissue while preserving the nipple and skin. The two methods are: using a cold scalpel (cold dissection) versus using an electrocautery tool (which uses heat/electricity to cut and seal tissue). Researchers want to see which method leads to better healing and fewer complications. **You may be eligible if...** - You have a breast tumor smaller than 5 cm - There is no sign of the cancer spreading to the nipple, skin, or chest wall - Your surgeon has determined you are a suitable candidate for nipple-sparing mastectomy **You may NOT be eligible if...** - Your cancer involves the nipple, skin, or chest wall - You have inflammatory or locally advanced breast cancer - You have serious health conditions like heart disease, kidney failure, or liver disease that increase surgical risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECold dissection

The subcutaneous flap dissection was performed with a scissor in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally. Our tumescent technique utilizes a solution made by mixing 0.2ml of epinephrine with 250 ml of 0.9% Sodium Chloride solution to create a 1‰ ratio. 150ml to 150ml of the solution was injected into the subcutaneous tissue of the operated breast with a 20-gauge spinal needle to establish a bloodless plane. The septa between the skin flap and parenchyma then was dissected using a scissor.

PROCEDUREElectrocautery Dissection

The subcutaneous flap dissection was performed with electrocautery in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally.