A comparison between high and low pressure continuous closed suction drainage systems - A prospective intra-individual randomized controlled study of drainage management after chest wall masculinization in female-to-male transgenders
Completed
- Conditions
- 10006295wound treatment after breast surgery
- Registration Number
- NL-OMON40288
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
- aged 18 or older;
- qualify for bilateral mastectomy in the context of FtM sex reassignment;
- indication for post-operative drainage use;
- ability to give informed consent,
- willing to participate.
Exclusion Criteria
- shows evidence of alcohol and/or drug abuse;
- has a local or general infection which could jeopardize the surgical objective;
- has proven or suspected hypersensitivity to materials;
- has immunosuppressive pathologies.
- has (a history of) breast cancer;
- has ongoing severe psychiatric illness or mental retardation or is unable to communicate adequately
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of the study is drain production over time (first peak, (3h<br /><br>post-operative), first 24h post-operative and total production), up to the<br /><br>point of removal of the drainage system.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- edema and fluid collection in surgical space (measured by ultrasound<br /><br>diagnostics);<br /><br>- device related adverse events (eg. blockage of drains);<br /><br>- daily pain and pain upon removal of the drains;<br /><br>- complications;<br /><br>- wound closure, and aesthetic result.<br /><br>- cost-effectiveness;<br /><br>- surgeon*s & (operating room) nurse*s preferences</p><br>