Association Between Female Hormonal Profile and Wound Healing Outcomes After Reduction Mammaplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Wound healing at 21 days postoperative
研究概览
简要总结
The goal of this observational study is to assess the relationship between female hormonal status and postoperative wound healing in reduction mammaplasty. The main questions it aims to answer are:
- Does wound healing differ depending on whether the operation takes place before or after ovulation in the menstrual cycle?
- Does estradiol have a positive effect on wound healing?
Participants with mammary hypertrophy will undergo reduction mammaplasty, and the investigators will measure their hormonal profile (LH, FSH, and estradiol) on the day of surgery.
详细描述
The study will be designed as a prospective, observational, single-center investigation including 84 cisgender female patients aged 18 years or older, presenting with a clear medical indication for reduction mammaplasty. The preoperative evaluation will include standard physical assessment and confirmation of coverage by the patient's health insurance provider.
Patients with a history of breast cancer, active tobacco use, corticosteroid or contraceptive intake, will be excluded from participation. The surgical procedure will be performed by a senior plastic surgeon under general anesthesia, following gold-standard technical and safety guidelines.
On the day of surgery, peripheral blood samples will be collected for the measurement of serum estradiol, progesterone, and luteinizing hormone (LH) concentrations. Postoperative wound care will be standardized, using Dermabond Prineo medical adhesive dressing maintained in place for 21 days.
The primary endpoint will be defined as complete wound healing at postoperative day 21.
To standardize the assessment and improve its reproducibility, "complete healing" is defined as a wound that no longer requires any dressing care and can be left exposed to air.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic breast hypertrophy
- •Premenopausal
排除标准
- •Previous breast reduction surgery
- •Menopausal status
- •Oral contraceptives
- •Corticosteroid therapy
- •History of breast cancer
- •Active smoking and use of nicotine substitution products
结局指标
主要结局
Wound healing at 21 days postoperative
时间窗: 21 days
Complete wound healing at day 21 will be evaluated in all patient groups and correlated with serum estradiol levels measured on the day of surgery. At this time point, complete healing is defined as a closed, fully epithelialized scar with only mild residual inflammation and no need for further dressings. Persistent crusting, discharge, or dehiscence exposing dermis or subcutaneous tissue will be classified as delayed healing and managed with continued dressing care. For consistency, "complete healing" is operationally defined as a wound that no longer requires any dressing and can remain exposed to air, and results will be documented using standardized photographs.
次要结局
- Wound dehiscence(21 days)
研究者
Giulia Frigerio
Principal Investigator, M.D.
University Hospital, Geneva