ClinicalTrials.gg
Not yet recruitingNCT07724145FEMHEALUpdated Jul 23, 2026

Association Between Female Hormonal Profile and Wound Healing

An observational study in Wound Healing, Wound Healing Complication and Estradiol, sponsored by University Hospital, Geneva. Not yet recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by University Hospital, Geneva · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
84
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Wound Healing
  • Wound Healing Complication
  • Estradiol

Keywords

  • wound healing
  • menstrual cycle
  • estradiol
  • hormones
  • dehiscence
  • reduction mammaplasty
03

In context

Lead sponsor

University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Symptomatic breast hypertrophy
  • Premenopausal

Exclusion criteria

Exclusion Criteria:

  • Previous breast reduction surgery
  • Menopausal status
  • Oral
  • therapy
  • History of breast cancer
  • Active smoking and use of nicotine substitution products
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
84 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 21 days

Secondary outcomes

  1. 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.

    Time frame: 21 days

Other outcomes

  1. Scar quality

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

    Time frame: 6 and 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Patient data will be kept anonymously in a secure facility. Only aggregated study results will be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Dec 2028, 29 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2026
First posted
Jul 23, 2026
StartEst.
Jul 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Jul 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07724145
Responsible party
Giulia Frigerio (Principal Investigator, M.D., University Hospital, Geneva) — Principal investigator
First posted
Jul 23, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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