Closed Incision Negative Wound Pressure Therapy on Wound Healing and Scar Quality After Mastectomies in Transgender Men.

Completed

• Conditions: mastectomy; 10040785; transgender; 10040795

• Registration Number: NL-OMON48586
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-09-08
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 85

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameters will concern wound healing complications (infection,<br /><br>seroma, hematoma, dehiscence, reoperation). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameters will concern the outcomes of scar quality (POSAS,<br /><br>SCAR-Q, Cutometer® and DSM-II colormetric evaluation). Additional endpoints<br /><br>will be revision surgery, CHEST-Q scores, nipple survival.</p><br>