Association Between Female Hormonal Profile and Wound Healing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Geneva
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic breast hypertrophy
Premenopausal
Disqualifiers
Previous breast reduction surgery
Menopausal status
Oral contraceptives
Corticosteroid therapy
Trial population
The project population will involve 84 women aged 18 years or older presenting with breast hypertrophy and scheduled for reduction mammoplasty
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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 daysSecondary 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 daysOther 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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: