L-Mesitran Soft and Tulle, 40% honey based wound care products, are FDA approved

MAASTRICHT, Netherlands - Jan. 22, 2016 - The FDA (Food and Drug Administration of the USA) approved the L-Mesitran Soft and Tulle products. The products are Rx and OTC cleared by the FDA via the 510(k) procedure. The products are produced by Theo Manufacturing BV a Dutch company and come in addition to their Hydro/Border/Net and Active dressings, now completing a full range of advanced wound care dressings based on honey for the US market. 

The products have a proven track record in the EU and other international markets. They maintain a moist wound care environment, important for wound healing.  L-Mesitran Soft is equally effective in treating (infected) burns as silver sulphadiazine (SSD), but L-Mesitran has the advantage that it at the same time stimulates tissue growth (epithelization) whereas SSD clearly has a slower (delayed) epithelization (Boekema, 2013). A prospective study shows that when used for chronic leg ulcers, L-Mesitran can aid speeding up the wound healing process significantly, reducing the mean time to wound healing (Tellechea, 2013).

L-Mesitran Soft contains 40% Medical Grade Honey and comes in tubes. L-Mesitran Tulle is an easy single use disposable presentation of a synthetic gauze impregnated with L-Mesitran Soft.

References:

Boekema B et al. (2013) The effect of a honey based gel and silver sulphadiazine on bacterial infections of in vitro burn wounds. Burns 39(4):754-759

Tellechea O et al. (2013) Efficacy of honey gel in the treatment of chronic lower leg ulcers: a prospective study. EWMA Journal 13(2):35-39

FDA information:

L-Mesitran Soft and Tulle: http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150676.pdf

L-Mesitran Hydro, Border, Net and Active: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053613.pdf

 

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