SafetyNCT06870695
Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty
An observational study of Safety and Efficiency, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate safety and efficiency of electrocautery de-epithelization in mammoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Safety, Efficiency, Electrocautery
- What is being tested?
- Electrocautery and Surgical blade by scalpel
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study was conducted on 100 females patients aged 18 years or older who were scheduled to undergo mammoplasty at Tanta University Hospitals, Egypt between July 2024 and February 2025
Who may be able to join
- Age ≥ 18 years.
- Patients undergoing mammoplasty.
Who cannot join
- Patients with active infections or open wounds at the surgical site.
- Individuals with known hypersensitivity or adverse reactions to electrocautery.
- Pregnant or lactating women.
- Patients with uncontrolled diabetes or coagulation disorders.
- History of psychiatric illness.
- Patients undergoing secondary or repeat breast reduction procedures.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate safety and efficiency of electrocautery de-epithelization in mammoplasty.
Read the detailed description
Mammoplasty is the fifth most commonly performed by plastic surgeons worldwide to improve symptomatology resulting from macromastia.
One of the key stages in a breast reduction or augmentation surgery is the de-epithelization process. De-epithelialization is the first stage of reduction mammoplasty in techniques that use dermal, dermo-glandular pedicles. Traditional methods of de-epithelization include manual dissection or mechanical scraping as time-consuming and demanding by most surgeons, especially when the breasts are large and when there is no assistant available.
- Conditions
- Safety, Efficiency, Electrocautery, De-Epithelization, Mammoplasty
- Being tested
- Electrocautery, Surgical blade by scalpel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocauteryProcedure or surgery
Patients undergoing standard surgical de-epithelization with electrocautery.
Surgical blade by scalpelProcedure or surgery
Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery group | Patients undergoing standard surgical de-epithelization with electrocautery. Receives: Procedure: Electrocautery | |
| Control group | Patients undergoing standard surgical de-epithelization using surgical blade by scalpel. Receives: Procedure: Surgical blade by scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time (time taken from skin incision to completion of skin closure). Operative time will be measured for each breast
Measured: Intraoperatively
Secondary outcomes (7)
Degree of pain
Degree of pain will be measured using a standard 10-point visual analog pain scale (VAS). The women verbally reported a pain rating for each breast first in the recovery room (within 4 hours of surgical stop) and again at the first follow-up visit (1 to 3 days after surgery).
Measured: 3 days after surgery
De-epithelization time
De-epithelization time will be recorded.
Measured: Intraoperatively
Time to achieve hemostasis
The time to achieve hemostasis will be assessed.
Measured: Intraoperatively
Duration of drain placement
Duration of drain placement will be recorded.
Measured: Intraoperatively
Blood loss
Blood loss will be assessed by weighing the swabs that will be used during the pedicle de-epithelialization process.
Measured: Intraoperatively
Wound healing time
Wound healing time will be recorded.
Measured: 6 weeks after surgery
Incidence of adverse events
The incidence of adverse events such as flap necrosis, hematoma, seroma, and surgical site infection will be recorded.
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jul 2024
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamdy Elghazaly, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870695
- Sponsor's protocol ID
- 36264PR1061/1/25
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty
- ClinicalTrials.gov ID
- NCT06870695
- Acronym / sponsor ID
- 36264PR1061/1/25
- Conditions
- Safety, Efficiency, Electrocautery, De-Epithelization, Mammoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 11 Mar 2025 (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 aim of this study is to evaluate safety and efficiency of electrocautery de-epithelization in mammoplasty.
Detailed description
Mammoplasty is the fifth most commonly performed by plastic surgeons worldwide to improve symptomatology resulting from macromastia.
One of the key stages in a breast reduction or augmentation surgery is the de-epithelization process. De-epithelialization is the first stage of reduction mammoplasty in techniques that use dermal, dermo-glandular pedicles. Traditional methods of de-epithelization include manual dissection or mechanical scraping as time-consuming and demanding by most surgeons, especially when the breasts are large and when there is no assistant available.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery group | – | Procedure: ElectrocauteryPatients undergoing standard surgical de-epithelization with electrocautery. |
| Control group | – | Procedure: Surgical blade by scalpelPatients undergoing standard surgical de-epithelization using surgical blade by scalpel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study was conducted on 100 females patients aged 18 years or older who were scheduled to undergo mammoplasty at Tanta University Hospitals, Egypt between July 2024 and February 2025
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- Patients undergoing mammoplasty.
Key exclusion criteria (6 listed)
- Patients with active infections or open wounds at the surgical site.
- Individuals with known hypersensitivity or adverse reactions to electrocautery.
- Pregnant or lactating women.
- Patients with uncontrolled diabetes or coagulation disorders.
- History of psychiatric illness.
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 |
|---|---|---|
| ElectrocauteryPatients undergoing standard surgical de-epithelization with electrocautery. | Procedure or surgery | Electrocautery group |
| Surgical blade by scalpelPatients undergoing standard surgical de-epithelization using surgical blade by scalpel. | Procedure or surgery | Control group |
Primary outcome
Operative time
Time frame: Intraoperatively
Operative time (time taken from skin incision to completion of skin closure). Operative time will be measured for each breast
7 secondary outcomes
Degree of pain
Time frame: 3 days after surgery
De-epithelization time
Time frame: Intraoperatively
Time to achieve hemostasis
Time frame: Intraoperatively
Duration of drain placement
Time frame: Intraoperatively
Blood loss
Time frame: Intraoperatively
Wound healing time
Time frame: 6 weeks after surgery
Incidence of adverse events
Time frame: 6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Efficiency, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 24 Mar 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperatively). 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 24 Mar 2025.