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Upper eyelid cooling.


- candidate number14235
- NTR NumberNTR3799
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2013
- Secondary IDsNL41646.042.12 MEC UMC Groningen
- Public TitleUpper eyelid cooling.
- Scientific TitleThe effects of cooling of the upper eyelid skin after upper eyelid blepharoplasty.
- ACRONYMBLE-COOL
- hypothesisIt is often advised to cool the upper eyelids immediately after an upper eyelid blepharoplasty and frequently in the first 24 hours in order to reduce pain and minimize edema and bruising of the upper eyelids. However, it has never been scientifically proven that cooling of the upper eyelids after upper eyelid blepharoplasty leads to less pain, edema, erythema and/or bruising after surgery. Besides that, cooling of the upper eyelids causes an unpleasant sensation in some patients. The results of this study may lead to a new advice regarding cooling of the upper eyelids after an upper eyelid blepharoplasty. If no differences are found in pain, swelling, redness and blue discoloration between the cooled and uncooled eyelids, in the future patients can deside whether or not to cool their upper eyelids depending on their own preference.
- Healt Condition(s) or Problem(s) studiedBlepharochalasis, Upper eyelid blepharoplasty, Ice pack, Cooling
- Inclusion criteriaPatients with blepharochalasis, who will have an upper eyelid blepharoplasty for that purpose in the Bergman Clinics Heerenveen or Zwolle upward of the 1st of January 2013.
- Exclusion criteriaPrevious surgery on the upper eyelids and the inability to understand a Visual Analogue Scale (from 0 to 10) or a 4-point ratingscale.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate31-dec-2013
- Target number of participants40
- InterventionsAll blepharoplasties were performed by one of four plastic surgeons who work in the Bergman Clinics. Drawing lots immediately after the operation determined which of the two upper eyelids would be cooled. The upper eyelid that has drawn for standard cooling was cooled with an ice pack during the first 30 minutes after the operation, another 15-20 minutes after returning home and 3x 15-20 minutes on the first day(s) after surgery. The other upper eyelid should not be cooled after surgery or at home.
- Primary outcomePain (on a Visual Analoque Scale from 0 to 10), degree of edema, erythema and bruising (on a 4-point rating scale with 0 = no, 1= slight/minimal, 2 = moderate and 3= severe/major).
- Secondary outcomeThe participants also noted to which eyelid they experienced or observed less pain, swelling, redness and bruising: the cooled eyelid, the uncooled eyelid or no difference. Finally, after one week all participants scored which treatment they have preferred: cooling, no cooling or no preference.
- TimepointsPain was scored by the patient the day of and one day after the operation. Degree of edema, erythema and bruising were scored by the patient before discharge, one day, one week and 6-8 weeks after the upper blepharoplasty. An observer also scored these three parameters on the basis of photographs taken before discharge, one week and 6-8 weeks after the operation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. Shariselle M.W. Pool
- CONTACT for SCIENTIFIC QUERIESMD. Shariselle M.W. Pool
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryTo investigate if cooling of the upper eyelids after an upper eyelid blepharoplasty leads to less pain, edema, erythema and/or bruising after the surgery.
- Main changes (audit trail)
- RECORD21-jan-2013 - 30-jan-2013


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