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van CCT (UK)

van CCT (UK)

Prevention of breast edema with a compression bra (CoBra)

- candidate number24131
- NTR NumberNTR5726
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-mrt-2016
- Secondary IDsV2016_3_10 
- Public TitlePrevention of breast edema with a compression bra (CoBra)
- Scientific TitlePrevention of breast edema with a compression bra: a case-control study
- hypothesisWearing a compression bra, early after surgery, will be preventive for the development of breast edema.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria-Female patients with breast cancer who will receive breast conserving surgery.
-Female patients that are candidates for plastic surgery (breast reduction or breast enlargement)
-Age > 18y
-Able to understand Dutch
-providing a signed informed consent
- Exclusion criteria-metastatic breast cancer
-DIEP-flap reconstructive surgery
-open wounds
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate30-sep-2018
- Target number of participants76
- InterventionsWearing a custom-made compression bra early after surgery
- Primary outcomeIncidence of breast edema
- Secondary outcome-Comfort compression bra
-Pressure (Picopress)
-Compression questionnaire
-Water content of dermis and subcutis
-QoL (McGill QoL Dutch)
- TimepointsT0 = baseline
T1 = 1mo FU
T2 = 3mo FU
T3 = 6mo FU
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESprof. dr. Nick Gebruers
- CONTACT for SCIENTIFIC QUERIESprof. dr. Nick Gebruers
- Sponsor/Initiator University of Antwerp, Antwerp University Hospital, Antwerp, Belgium
- Funding
(Source(s) of Monetary or Material Support)
Juzo Gmbh, Tricolast NV
- PublicationsVerbelen H, Gebruers N, Beyers T, De Monie AC, Tjalma W. Breast edema in breast cancer patients following breast-conserving surgery and radiotherapy: a systematic review. Breast Cancer Res Treat. 2014 Oct;147(3):463-71. doi: 10.1007/s10549-014-3110-8. Epub 2014 Aug 28. PubMed PMID: 25164973.
- Brief summary
- Main changes (audit trail)
- RECORD21-mrt-2016 - 11-dec-2016

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