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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
-
-
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Geneva, Svizzera, 1205
- University Hospital of Geneva
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Contatto:
- Giulia Frigerio, MD
- Numero di telefono: +41795533139
- Email: giulia.frigerio@hug.ch
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Contatto:
- Axelle Serre, MD
- Numero di telefono: +41795538642
- Email: axelle.serre@hug.ch
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Investigatore principale:
- Axelle Serre, MD
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Investigatore principale:
- Giulia Frigerio, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Wound healing at 21 days postoperative
Lasso di tempo: 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.
|
21 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Wound dehiscence
Lasso di tempo: 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.
|
21 days
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Scar quality
Lasso di tempo: 6 and 12 months
|
Wound quality will be assessed at 6 and 12 months postoperatively using the Vancouver Scar Scale (VSS).
|
6 and 12 months
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2026-00368
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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