Association Between Female Hormonal Profile and Wound Healing (FEMHEAL)

Association Between Female Hormonal Profile and Wound Healing Outcomes After Reduction Mammaplasty

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing; Wound Healing Complication; Estradiol

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.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University Hospital of Geneva
    • Contact: Giulia Frigerio, MD; Phone Number: +41795533139; Email: giulia.frigerio@hug.ch
    • Contact: Axelle Serre, MD; Phone Number: +41795538642; Email: axelle.serre@hug.ch
    • Principal Investigator: Axelle Serre, MD
    • Principal Investigator: Giulia Frigerio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The project population will involve 84 women aged 18 years or older presenting with breast hypertrophy and scheduled for reduction mammoplasty

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing at 21 days postoperative	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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound dehiscence	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.	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar quality	Wound quality will be assessed at 6 and 12 months postoperatively using the Vancouver Scar Scale (VSS).	6 and 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: menstrual cycle; estradiol; wound healing; hormones; dehiscence; reduction mammaplasty
• Other Study ID Numbers: 2026-00368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data will be kept anonymously in a secure facility. Only aggregated study results will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No