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NCT Number: NCT07724145

Association Between Female Hormonal Profile and Wound Healing

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Wound healing at 21 days postoperative

    Time frame: 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.

Secondary outcomes

  1. Wound dehiscence

    Time frame: 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.

Other outcomes

  1. Scar quality

    Time frame: 6 and 12 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: FEMHEAL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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