Non‐interventional study to investigate the efficacy and safety of Tegaderm™ Matrix in the treatment of patients with therapy‐refractory chronic wounds

Weindorf, Maren; Körber, Andreas; Klode, Joachim; Dissemond, Joachim

doi:10.1111/j.1610-0387.2011.07828.x

Cited by 5 publications

(2 citation statements)

References 24 publications

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“…Thin elastic polymer films have been used for decades in medical practice, inter alia for the transparent covering of wounds, sutures or catheter access points (7,10,28). In order to position such highly flexible films on the skin, they usually consist of a basic and a covering film as carrier and stabilising material, respectively.…”

Section: Schlüsselwörtermentioning

confidence: 99%

Film compression bandage

Ragg¹

2015

Phlebologie

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KeywordsFilm bandage, compression, sports, varicose vein, foam sclerotherapy SummaryPurpose: 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 sclerotherapy. 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, induration 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.

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