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

NCT06024187 | Recruiting DMC

• 1 other identifier: SYSKY-2022-371-02
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

Endoscopy; Mastectomy; Breast Implants; Necrosis; Dissection

Outcome Measures

Primary Outcomes (1)

• 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.

  Within one month post operation

Secondary Outcomes (12)

• Necrotic complications within 1 year post operation

  Within 1 year post operation

• Surgical-site infection rate(SSI)

  within one year post operation

• The incidence of postoperative complications

  within one year post operation

• Cosmetic outcomes evaluated by 5-point Likert Scale

  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)

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

Study Arms (2)

Cold Dissection

EXPERIMENTAL

In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel

Procedure: Cold dissection

Electrocautery Dissection

ACTIVE COMPARATOR

In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery

Procedure: Electrocautery Dissection

Interventions

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.

Cold Dissection

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.

Electrocautery Dissection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tumor smaller than 5 cm
• No evidence of NAC, skin or chest wall invasion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Shicheng Su

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Necrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Shicheng Su

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shicheng Su

CONTACT

+86 13631304227; sushch@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who met the inclusion criteria and received informed consent were randomly assigned to the group of using cold separation or the group of using electrocautery with 1:1 allocation based on a computer-generated randomization schedule. The randomization was conducted by drawing an envelope containing the allocation to one of the two intervention groups.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: September 6, 2023
• Study Start: November 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (1)