Breast NeoplasmsNCT06024187
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
A study testing Cold dissection and Electrocautery Dissection in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Cold dissection and Electrocautery Dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shicheng Su
Guangzhou, Guangdong, 510120
Shicheng Su, M.D.,Ph.D., +8613631304227, sushch@mail.sysu.edu.cn
About this study
Official title: Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective 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.
Read the detailed description
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.
- Conditions
- Breast Neoplasms
- Being tested
- Cold dissection, Electrocautery Dissection
- Keywords
- Endoscopy, Mastectomy, Breast Implants, Necrosis, Dissection
- Medical subject headings
- Breast Neoplasms, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold dissectionProcedure or surgery
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 DissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold Dissection | Experimental | In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel Receives: Procedure: Cold dissection |
| Electrocautery Dissection | Active comparator | In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery Receives: Procedure: Electrocautery Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one month post operation
Secondary outcomes (12)
Necrotic complications within 1 year post operation
Measured: Within 1 year post operation
Surgical-site infection rate(SSI)
the incidence of surgical-site infection will be compared between two groups
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Immediate post operation
Intraoperative estimated blood loss
Blood loss (ml) during operation was compared between groups
Measured: Immediate post operation
Drain volume
Total drain volume(ml) within three days post operation
Measured: within three days post operation
Duration of hospital stay post operation
Duration of hospital stay post operation(d) will be compared between two group.
Measured: Within 2 weeks of operation.
Weight of the excised gland
Mean mastectomy weight of patients will be compared between two groups.
Measured: Immediate post operation
Size of implant
Size of implant will be compared between two groups.
Measured: Immediate post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start23 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 566 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shicheng Su, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024187
- Sponsor's protocol ID
- SYSKY-2022-371-02
- Status last verified
- Feb 2025
- First submitted
- 30 Nov 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06024187
- Acronym / sponsor ID
- SYSKY-2022-371-02
- Conditions
- Breast Neoplasms
- Keywords
- Endoscopy, Mastectomy, Breast Implants, Necrosis, Dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold Dissection | Experimental | Procedure: Cold dissectionIn this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel |
| Electrocautery Dissection | Active comparator | Procedure: Electrocautery DissectionIn this group, the septa between the skin flap and parenchyma was dissected using with electrocautery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold dissectionThe 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. | Procedure or surgery | Cold Dissection |
| Electrocautery DissectionThe 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. | Procedure or surgery | Electrocautery Dissection |
Primary outcome
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.
12 secondary outcomes
Necrotic complications within 1 year post operation
Time frame: Within 1 year post operation
Surgical-site infection rate(SSI)
Time frame: within one year post operation
The incidence of postoperative complications
Time frame: within one year post operation
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.
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.
Postoperative pain
Time frame: Evaluated at the first day, second day, third day and the first week, second week.
Total operation time
Time frame: Immediate post operation
Intraoperative estimated blood loss
Time frame: Immediate post operation
Drain volume
Time frame: within three days post operation
Duration of hospital stay post operation
Time frame: Within 2 weeks of operation.
Weight of the excised gland
Time frame: Immediate post operation
Size of implant
Time frame: Immediate post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shicheng Su principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold dissection and Electrocautery Dissection in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shicheng Su (+86 13631304227, sushch@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Necrosis complications within one month post operation (time frame: Within one month post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.