Association Between Female Hormonal Profile and Wound Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Wound Healing, Wound Healing Complication, Estradiol. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Female Hormonal Profile and Wound Healing Outcomes After Reduction Mammaplasty
Overview
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: 1. Does wound healing differ depending on whether the operation takes place before or after ovulation in the menstrual cycle? 2. 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.
Detailed description
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.
Wound healing outcomes will be correlated and analyzed in relation to serum hormone levels measured on the day of surgery. Standard postoperative follow-up visits will be scheduled at 48 hours, 7 days, 21 days, 6 weeks, and at 3-, 6-, and 12-months post-surgery.
Primary outcome measures
- Wound healing at 21 days postoperative [Time frame: 21 days]
Secondary outcome measures (1)
- Wound dehiscence [Time frame: 21 days]
Eligibility criteria
Inclusion criteria
- Symptomatic breast hypertrophy
- Premenopausal
Exclusion criteria
- Previous breast reduction surgery
- Menopausal status
- Oral contraceptives
- Corticosteroid therapy
- History of breast cancer
- Active smoking and use of nicotine substitution products
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Hospital of Geneva — Geneva
Identifiers
NCT: NCT07724145 · 2026-00368