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Effects of discharge with a surgical drain in place on the risk of infection after placement of a tissue expander


- candidate number28365
- NTR NumberNTR6927
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-dec-2017
- Secondary IDsNL 64530 RTPO Leeuwarden
- Public TitleEffects of discharge with a surgical drain in place on the risk of infection after placement of a tissue expander
- Scientific TitleEffects of discharge with drain in situ on the risk of infection after placement of a tissue expander.
- ACRONYM
- hypothesisPatients 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.
- Healt Condition(s) or Problem(s) studiedInfection, Tissue expander, Breast reconstruction, Surgical drain
- Inclusion criteriaWomen >18 years with a post-mastectomy reconstruction with a tissue expander
- Exclusion criteriaInsufficient self-care, the inability to be sufficiently instructed on how to care for the drain. (aliteracy, language-barrier, mental retardation, psychiatric disorders)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-feb-2018
- planned closingdate1-feb-2020
- Target number of participants80
- InterventionsThis 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.
- Primary outcomeThe primary study parameter is the percentage of removed tissue expanders due to infection.
- Secondary outcomeThe secondary study parameter is the percentage of patients who get a prescription for antibiotics due to infection (IV or/and oral antibiotics).
- TimepointsOutcome: 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. SJM Jongen
- CONTACT for SCIENTIFIC QUERIESDrs. SJM Jongen
- Sponsor/Initiator Martini Hospital Groningen
- Funding
(Source(s) of Monetary or Material Support)
Martini Hospital Groningen
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD21-dec-2017 - 11-jan-2018


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