None listed
Conditions
Brief summary
The primary purpose of this trial is to investigate whether the use microporous polysaccharide hemosphere (MPH) reduces the rate of seroma formation in breast cancer patients following mastectomy. Who is it for? You may be eligible to enrol in this trial if you are aged over 18 and have been diagnosed with breast cancer for which you are scheduled to undergo a mastectomy with or without sentinel lymph node biopsy, and with or without axillary lymph node dissection. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either MPH or no MPH applied to the wound prior to wound closure. All participants will be followed up at 2 weeks following surgery to assess the wound site for seroma (fluid pockets). It is hoped that this trial will provide information on whether MPH is effective in the prevention of seroma in breast cancer patients following mastectomy.
Interventions
100 sequential patients are randomly assigned to control (n = 50) or experimental groups (n = 50).
The patients in the experimental group receive the MPH powder (1 gram) topically throughout the wound bed prior to closure, whereas the patients assigned to the control group receive no treatment.
Incisions are closed with interrupted dermal sutures with Vicryl 2/0 and a running subcuticular stitch of Monocryl 3/0.
Pressure dressings (Combine and Hypafix) are used overnight.
Drains are not used
100 sequential patients are randomly assigned to control (n = 50) or experimental groups (n = 50). The patients in the experimental group receive the MPH powder (1 gram) topically throughout the wound bed prior to closure, whereas the patients assigned to the control group receive no treatment. Incisions are closed with interrupted dermal sutures with Vicryl 2/0 and a running subcuticular stitch of Monocryl 3/0. Pressure dressings (Combine and Hypafix) are used overnight. Drains are not used. The patients are examined at their first clinic appointment (5-10 days post operatively) for the presence of a seroma and any palpable fluid collections were aspirated percutaneously. Subsequent seroma aspiration timing and volumes are recorded.
Sponsors
Diana Tam
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The patients will be recruited sequentially from the breast clinics at Robina Hospital (ie women aged over 18 presenting with confirmed invasive or in-situ breast cancer who decide to proceed with a mastectomy +/- axillary surgery).
Exclusion criteria
Reconstructive surgery
Outcome results
None listed