NL-OMON48586
Completed
Not Applicable
Closed Incision Negative Wound Pressure Therapy on Wound Healing and Scar Quality After Mastectomies in Transgender Men. - PICO-trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- mastectomy
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 85
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Trans men requiring a mastectomy.
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
Outcomes
Primary Outcomes
Not specified
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