Wondgenezing, post-operatieve complicaties en pathologische littekenvorming. Wound healing, post-operative complications and pathological scar formation.
Conditions
Interventions
The bilateral mastectomy sites will be closed conventionally and in accordance to standard practice. All mastectomies will be randomly assigned one control side and one case side that will receive th
Sponsors
AUMC, locatie VUmc
Eligibility
Inclusion criteria
Inclusion criteria: • Only patients that meet the age criterion of >18 years old will be considered for participation. • Written informed consent by the patient and/or legal representative • Trans men that request a bilateral mastectomy as a masculinization procedure.
Exclusion criteria
Exclusion criteria: • Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing) • Severe drug, smoking (> 1 pack a day; 22 cigarettes) and alcohol abuse (>10 alcoholic units a week) • Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameters will concern wound healing complications (infection, seroma, hematoma, dehiscence, reoperation). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters will concern the outcomes of scar quality (POSAS, Cutometer®, SCAR-Q and DSM-II colormetric evaluation). Additional endpoints will be revision surgery, CHEST-Q scores, nipple survival and nipple sensitivity. | — |
Contacts
Public ContactF.W. Timmermans
Outcome results
None listed