The primary objective of the study is to objective if there is a greater risk of loss of the tissue expander due to infection if patients are discharged with a surgical drain in situ.
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the percentage of removed tissue expander due to
infection.
Secondary outcome
The secondary study parameter is the percentage of patients who get a
prescription for antibiotics due to infection (IV or/and oral antibiotics).
Background summary
All women undergoing a mastectomy with reconstruction by tissue expander or
final prothesis have a surgical drain postoperatively. The drain is removed on
the 7th postoperative day or if the drain produces less than 30ml per 24 hours.
Patients will often make a rapid recovery and most are ready for discharge
within a few days, which means they will have to remain in the hospital until
the drain can be removed. Caring for a drain is a simple procedure which can be
performed by the patient if they receive a thorough instruction. Discharging
patients with a drain in situ could potentially reduce the duration of hospital
stay considerably.
Study objective
The primary objective of the study is to objective if there is a greater risk
of loss of the tissue expander due to infection if patients are discharged with
a surgical drain in situ.
Study design
This study is a prospective randomized control-trial. This study divides the
subjects into two groups. The first group will receive care as usual, in which
the patients will stay in the hospital until the drain is removed. (on the 7th
postoperative day at the latest) The second group will be discharged on the 3rd
postoperative day with a surgical drain in situ. They will receive written and
verbal instruction, on how to take care of the drain, prior to discharge.
Patients will have an additional check-up in an outpatient unit on the 5th
postoperative day. On the 7th postoperative day the patients always have an
appointment with the surgeon to discuss the results of the pathology report,
this appointment will combined with the appointment for removing the drain.
Patients are instructed to make an appointment for removal of the drain if it
produces less than 30ml in 24 hours before the 7th day.
Study burden and risks
Patients that are discharged with a drain in situ will have a minimum of 1 (for
wound inspection on the 5th postoperative day) and a maximum of 2 additional
appointments (an additional visit to remove the surgical drain before the 7th
post-operative day) in comparison to patients receiving the regular treatment.
These additional visits and clear instructions on how to take care of the drain
will reduce the possibility of an increased risk of infection, by participating
in this study, to a minimum. Patients will still receive the same treatment,
but just in another location (home).
Van Swietenplein 1
Groningen 9728NT
NL
Van Swietenplein 1
Groningen 9728NT
NL
Listed location countries
Age
Inclusion criteria
Women >18 years with a post-mastectomy reconstruction with a tissue expander.
Exclusion criteria
Insufficient self-care, the inability to be sufficiently instructed on how to
care for the drain. (aliteracy, language-barrier, mental retardation,
psychiatric disease )
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 28365 |
| CCMO | NL64530.099.17 |
| OMON | NL-OMON28105 |