An interventional study of Cold dissection and Electrocautery Dissection in Breast Neoplasms, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
Breast cancer is the most common cancer among women in the world. Although breast-conserving surgery is a viable option for patients, mastectomy remains the choice of treatment. Despite oncologic and surgical safety of nipple-sparing mastectomy(NSM) with immediate breast reconstruction(IBR) were amply demonstrated, a number of acute and late complications can occur. Surgical technique may play a role in the postoperative outcomes of mastectomy skin flap.Previous studies suggest that cold dissection with scissors or scalpel, may lead to decreasing blood loss and rates of skin necrosis, compared to electrocautery. A retrospective study by Troy Ng demonstrated that the use of cold dissection is likely to decrease the rate of partial-thickness necrosis (13.0%→33.3%, p=0.01) and full-thickness necrosis (1.3%→12.8%, p=0.02). 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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 566 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel
Procedure: Cold dissection
In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery
Procedure: Electrocautery 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.
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.
Necrosis complications within one month post operation
Necrosis complications included nipple-areolar complex (NAC) and skin flap necrosis. NAC/skin flap necrosis could present as minor superficial epidermolysis requiring local wound care only, or full-thickness necrosis with any exposure of acellular dermal matrix, muscle, implant, or with full-thickness eschar that required surgical reoperation of debridement and repair.
Time frame: Within one month post operation
Necrotic complications within 1 year post operation
Time frame: Within 1 year post operation
Surgical-site infection rate(SSI)
the incidence of surgical-site infection will be compared between two groups
Time frame: within one year post operation
The incidence of postoperative complications
the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups
Time frame: within one year post operation
Cosmetic outcomes evaluated by 5-point Likert Scale
Evaluated by patients and five surgeons. In this scale, breast fullness; nipple-areola complex, shape, and contour; scar appearance, size, and fullness; and overall breast appearance will be assessed.
Time frame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
Patient-reported outcomes (as measured using the BREAST-Q score)
The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.
Time frame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
Postoperative pain
Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.
Time frame: Evaluated at the first day, second day, third day and the first week, second week.
Total operation time
Defined as the time calculated from the skin incision to the end of wound closure
Time frame: Immediate post operation
Intraoperative estimated blood loss
Blood loss (ml) during operation was compared between groups
Time frame: Immediate post operation
Drain volume
Total drain volume(ml) within three days post operation
Time frame: within three days post operation
Duration of hospital stay post operation
Duration of hospital stay post operation(d) will be compared between two group.
Time frame: Within 2 weeks of operation.
Weight of the excised gland
Mean mastectomy weight of patients will be compared between two groups.
Time frame: Immediate post operation
Size of implant
Size of implant will be compared between two groups.
Time frame: Immediate post operation
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University