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NCT Number: NCT06024187

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Necrosis Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shicheng Su

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Shicheng Su, M.D.,Ph.D.

CONTACT

[email protected]

+8613631304227

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tumor smaller than 5 cm
  • No evidence of NAC, skin or chest wall invasion.
  • The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to E-NSM as well.

Exclusion criteria

  • Patients with apparent NAC involvement, chest wall or skin invasion, inflammatory breast cancer, locally advanced breast cancer or severe comorbid conditions or poor performance status assessed by the primary physicians, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians.

Treatment and study plan

Cold dissection

Procedure

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.

Electrocautery Dissection

Procedure

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.

Primary outcomes

  1. Necrosis complications within one month post operation

    Time frame: 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.

Secondary outcomes

  1. Necrotic complications within 1 year post operation

    Time frame: Within 1 year post operation

  2. Surgical-site infection rate(SSI)

    Time frame: within one year post operation

    the incidence of surgical-site infection will be compared between two groups

  3. The incidence of postoperative complications

    Time frame: within one year post operation

    the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups

  4. Cosmetic outcomes evaluated by 5-point Likert Scale

    Time frame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.

    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.

  5. Patient-reported outcomes (as measured using the BREAST-Q score)

    Time frame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.

    The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.

  6. Postoperative pain

    Time frame: Evaluated at the first day, second day, third day and the first week, second week.

    Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.

  7. Total operation time

    Time frame: Immediate post operation

    Defined as the time calculated from the skin incision to the end of wound closure

  8. Intraoperative estimated blood loss

    Time frame: Immediate post operation

    Blood loss (ml) during operation was compared between groups

  9. Drain volume

    Time frame: within three days post operation

    Total drain volume(ml) within three days post operation

  10. Duration of hospital stay post operation

    Time frame: Within 2 weeks of operation.

    Duration of hospital stay post operation(d) will be compared between two group.

  11. Weight of the excised gland

    Time frame: Immediate post operation

    Mean mastectomy weight of patients will be compared between two groups.

  12. Size of implant

    Time frame: Immediate post operation

    Size of implant will be compared between two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Shicheng Su

CONTACT

[email protected]

+86 13631304227

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 6, 2023
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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