Summary
Purpose: Textile compression stockings or bandages are limited in comfort; they do not allow
uninterrupted wearing. A novel elastic film bandage was evaluated regarding practicability,
patient comfort and effect on vein regression. Main endpoint was the frequency of
symptomatic inflammatory reactions.
Methods: In a comparative pilot study, a compression film bandage (CFB, investigational) comprising
an elastic, self-adhesive breathable polymer film of d <20 µm was continuously worn
for 14 d after foam sclero-therapy. Inclusion: 62 patients (26–68 y.) frequently doing
sports and taking daily showers, 90 legs with superficial varicosities, 5–12 mm ø
(MW: 7.3 mm), randomized to A) CFB + medical compression stocking (MCS), B) MCS alone,
C) CFB alone. Follow-up examinations including ultrasound and photography were performed
after 2, 4 and 8 weeks.
Results: Continuous wearing time of 14 days was completed in 57/60 cases with CFB (95.0 %,
A+C), while 3/60 (5.0 %) finished wearing after 8–10 d. There were no adverse skin
reactions except minor irritations at the upper edge (n = 2). Vein diameters were
reduced within 14 days by 29–54 % (mean: 43.5 %) in group A, 16–44% (mean: 39.1 %)
in group B, and 24–50 % (mean: 37.3 %) in group C. Symptomatic inflammation, indu-ration
or discolouration was observed within 28 days in 5/60 cases (8.3 %) when using CFB
(A, C) versus 19/30 (63.3%) related to stocking compression (B). Comfort was rated
by the patients 6.6 (A), 4.3 (B) and 9.2 (C) on a 10 degree scale. This difference
was statistically highly significant (p <0.01).
Conclusions: The film bandage is an effective and safe compression modality. For superficial varicosities
the adhesive bond to the skin seems to be relevant additional to the elastic properties.
The device significantly improves vein regression of foam-treated superficial varicosities
when combined with compression stockings or even as stand-alone modality. Continuous
wearing for two weeks is well tolerated. The bandage may also offer an alternative
for patients not tolerating textile compression media, or during summer.
Keywords Film bandage - compression - sports - varicose vein - foam sclerotherapy
