wound treatment after breast surgery
Conditions
Interventions
All study subjects will receive the most suitable surgical technique of chest
wall masculinization based on breast tissue volume and ptosis, and skin
elasticity and surplus (Cregten-Escobar et al.,
Monstrey et al., 2008).
At the end of the surgery the specialist will leave one high and one low vacuum
continuous closed suction drainage system in situ according to pre-operative
randomization:
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is drain production over time (first peak, (3h post-operative), first 24h post-operative and total production), up to the point of removal of the drainage system. | — |
Secondary
| Measure | Time frame |
|---|---|
| - edema and fluid collection in surgical space (measured by ultrasound diagnostics); - device related adverse events (eg. blockage of drains); - daily pain and pain upon removal of the drains; - complications; - wound closure, and aesthetic result. - cost-effectiveness; - surgeon*s & (operating room) nurse*s preferences | — |
Countries
Netherlands
Outcome results
None listed