Association Between Female Hormonal Profile and Wound Healing

NCT07724145 | Not Yet Recruiting

• 1 other identifier: 2026-00368
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does wound healing differ depending on whether the operation takes place before or after ovulation in the menstrual cycle?
2. 2.Does estradiol have a positive effect on wound healing?

Conditions

Wound Healing; Wound Healing Complication; Estradiol

Keywords

wound healing; menstrual cycle; estradiol; hormones; dehiscence; reduction mammaplasty

Outcome Measures

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.

  21 days

Secondary Outcomes (1)

• Wound dehiscence

  21 days

Other Outcomes (1)

• Scar quality

  6 and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Symptomatic breast hypertrophy
• Premenopausal

You may not qualify if:

• Previous breast reduction surgery
• Menopausal status
• Oral contraceptives
• Corticosteroid therapy
• History of breast cancer
• Active smoking and use of nicotine substitution products

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital of Geneva

Geneva, 1205, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: July 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)