No registrations found.
ID
Source
Health condition
Infection, Tissue Expander, Surgical drain, Breastreconstruction
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the percentage of removed tissue expanders 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
This study is a randomised control trial to assess if patients can be discharged homewards with a surgical drain in situ, after reconstruction with a tissue-expander post-mastectomy, without an increase in removal of tissue expanders due to infection.
There will be two groups. One will receive care as usual and will be discharged after removal of the drain (on the 7th post-operative day at the latest)
The other group will be discharged on the 3th post-operative day with drains in situ after receiving instructions on drain-care.
The percentages of removal of tissue-expanders due to infection and antibiotics usage due to infection will be registered and compared.
Study objective
Patients can be discharged, after a post-mastectomy reconstruction with a tissue expander, with a surgical drain in situ without an increase in the removal of tissue expanders due to infection.
Study design
Outcome: percentage of patients in which the tissue expander had to be removed due to infection, timepoint: within 21 days after the surgery.
Outcome: percentage of patients receiving AB due to infection, timepoint: within 21 days after the surgery.
Intervention
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 after receiving instructions on how to take care of the drain.
SJM Jongen
Van Swietenplein 1
Groningen 9728 NT
The Netherlands
SJM Jongen
Van Swietenplein 1
Groningen 9728 NT
The Netherlands
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 disorders)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6749 |
| NTR-old | NTR6927 |
| CCMO | NL64530.099.17 |
| OMON | NL-OMON50301 |