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

Effects of discharge with drain in situ on the risk of infection after placement of a tissue expander.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28105
Enrollment
80
Registered
2017-12-21
Start date
2018-02-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Tissue Expander, Surgical drain, Breastreconstruction

Interventions

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 a

Sponsors

Martini Ziekenhuis Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women >18 years with a post-mastectomy reconstruction with a tissue expander

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
The primary study parameter is the percentage of removed tissue expanders due to infection.

Secondary

MeasureTime frame
The secondary study parameter is the percentage of patients who get a prescription for antibiotics due to infection (IV or/and oral antibiotics).

Contacts

Public ContactSJM Jongen

Department of plastic surgery, Martini Ziekenhuis Groningen

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)