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:
- 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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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Geneva, Zwitserland, 1205
- University Hospital of Geneva
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Contact:
- Giulia Frigerio, MD
- Telefoonnummer: +41795533139
- E-mail: giulia.frigerio@hug.ch
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Contact:
- Axelle Serre, MD
- Telefoonnummer: +41795538642
- E-mail: axelle.serre@hug.ch
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Hoofdonderzoeker:
- Axelle Serre, MD
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Hoofdonderzoeker:
- Giulia Frigerio, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Wound healing at 21 days postoperative
Tijdsspanne: 21 days
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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.
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21 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Wound dehiscence
Tijdsspanne: 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.
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21 days
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Scar quality
Tijdsspanne: 6 and 12 months
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Wound quality will be assessed at 6 and 12 months postoperatively using the Vancouver Scar Scale (VSS).
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6 and 12 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2026-00368
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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