mastectomy transgender
Conditions
Interventions
Both 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 the additi
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Trans men requiring a mastectomy.
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) - Allergy to silver or acrylic adhesives: PICO* has an acrylic adhesive coating and a skin interface layer with silver, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives
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, SCAR-Q, Cutometer® and DSM-II colormetric evaluation). Additional endpoints will be revision surgery, CHEST-Q scores, nipple survival. | — |
Countries
Netherlands
Outcome results
None listed