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. 2021 Oct 12;2021(10):CD012723. doi: 10.1002/14651858.CD012723.pub2

Kern 2007.

Study characteristics
Methods Study design: prospective, randomised open‐label study
Method of randomisation: computer‐generated random table
Blinding: participant ‐ no; treating doctor ‐ no; outcome assessors ‐ yes
Power calculation: precalculation of the sample required size showed that to detect a true difference of half a standard deviation at a 1‐sided 5% significance level with a power of 80%
Total number of participants: 100 consecutive participants
Total number of procedures: 100
Treatment localisation: lateral aspect of the thigh
Number of exclusions post‐randomisation: none
Number of withdrawals and reasons: 4 lost to follow‐up
Participants Setting: outpatient site
Country: Switzerland
Gender: women
Age: median 47 years (range 20 ‐ 72)
Inclusion criteria: primary telangiectasias and reticular veins on the lateral aspect of the thigh (C1A or SEPAS1PN), women with aesthetic problems and normal duplex who sought treatment for the first time
Exclusion criteria: previous sclerotherapy and allergy to chrome
Interventions Treatment 1: sclerotherapy (chromated glycerin) plus compression
Treatment 2: sclerotherapy (chromated glycerin) without compression
Technique: "The patients had comparable types and sizes of telangiectasias and reticular veins: the diameter of reticular veins ranged between 1 to 2.9 mm, that of telangiectasias between 0.2 and 1 mm. These vessels could be identified from a distance of 2 meters by the human eye and the camera. One lower limb per patient was treated in a single session. If both thighs were affected, only the left one was treated and evaluated for the study as defined by the protocol. The whole treated thigh area was photographed immediately before sclerotherapy in supine position in order to avoid arbitrary selection of a limited skin surface. The same digital camera (Coolpix 990, Nikon, Tokyo, Japan), lighting conditions (flash), and focal distance were used. Chromated glycerin (Scleremo, Laboratoires Bailleul, Paris, France) was used in all patients as the sclerosing agent. Injections were performed with a 2 mL silicone syringe and a 30 G ½‐inch needle with the patient in supine position. Sixty to 100 injections were made on the lower limb during the session. The maximum amount of sclerosing solution injected was 10 mL per patient. Reticular feeding veins were injected prior to injection of the telangiectasias. Patients remained supine for 5 minutes after the last injection. In the compression group, a thigh‐length stocking Sigvaris 702 Top Fine (23 ‐ 32 mm Hg) was applied respecting the individual lower limb dimensions. Patients were asked to wear the compression stockings daily for 3 weeks and to remove it during night time. Patients filled in a quality of life questionnaire (SF‐36) prior to treatment."
Duration of follow‐up: 3 weeks
Use of compression: compression stocking
Outcomes Outcomes assessed by participant satisfaction analysis and quantitative evaluation of photographs taken from the lateral aspect of the thigh before and again at 52 days on the average after sclerotherapy by 2 blinded expert reviewers
Quality of life: participants completed a quality‐of‐life questionnaire (SF‐36) before treatment and again at the control
Funding sources No details provided
Declarations of interest None declared
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Prior to treatment, each participant was randomly assigned (computer‐generated random table) either to no compression or to compression for 3 weeks following sclerotherapy
Allocation concealment (selection bias) Unclear risk No details given
Blinding of participants and personnel (performance bias)
All outcomes High risk Impossible to blind participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Analysis of the photographs using the vessel disappearance score revealed a very good agreement between the 2 independently‐working blinded reviewers (intraclass correlation coefficient 0.93)
Incomplete outcome data (attrition bias)
All outcomes Low risk 3 withdrawals from the without‐compression group and 1 withdrawal from the chromated glycerin group
Selective reporting (reporting bias) Unclear risk No details given
Other bias Unclear risk No details given