Wednesday, 24 February 2016

Use of Modified Polysaccharide 4DryField ® PH for Adhesion Prevention and Hemostasis in Gynecological Surgery: A Two-Center Observational Study by Second-Look Laparoscopy.

2016;2016:3029264. Epub 2016 Jan 24.


Purpose. This study evaluates both scopes of 4DryField PH, certified for adhesion prevention and hemostasis, in patients undergoing surgery for various and severe gynecological disorders. Methods. This is a two-institutional study. Adhesion prevention efficacy was evaluated using video documentation of first-look laparoscopies (FLL) and second-look laparoscopies (SLL); other patient data were analyzed retrospectively. Twenty patients with various disorders were evaluated, 4 assigned to a uterus pathology, 10 to endometriosis, and 6 to an adhesion disease group. Nine patients received 4DryField primarily for hemostasis and 11 solely for adhesion prevention. Nineteen patients had SLL after 5 to 12 weeks and one after 13 months. Results. At FLL with 4DryField, immediate hemostasis could be achieved in diffuse bleeding. At SLL, effective adhesion prevention was observed in 18 of all 20 women, with only 2 revealing major adhesions. In particular, only 1 of the 6 women with adhesion disease as predominant disorder showed major adhesions at SLL. Conclusions. Modified polysaccharide 4DryField is not only effective in diffuse bleeding. In this cohort with extensive surgery for various gynecological pathologies, 4DryField showed effective adhesion prevention as confirmed at SLL, too. Its use as premixed gel is a convenient variant for treatment of large peritoneal wounds.

4DryField® PH
4DryField® PH is an innovative product concerning Hemostasis plus Adhesions prevention for several surgical fields of application. 4DryField® PH is an absorbable starch powder for application to surgical wounds by physicians or medical-technical specialists.
4DryField® PH consists of hydrophilic microparticles produced from purified starch of plant-based origin. 4DryField® PH is ready-to-use and can be applied directly to bleeding or oozing surfaces. The free flowing properties of 4DryField® PH permit simple and safe application during surgical interventions.
4DryField® PH absorbs within seconds a multiple of its own mass of water, which induces two effects:
Hemostasis plus Adhesion prevention combined in one medical device.
Hemostasis: Rapid water absorption transforms the wound blood into the patient’s own “fibrin glue” formatting a highly efficient coagulum to the wound.
Adhesions prevention: In presence of water 4DryField® PH particles form a gel, which acts as a temporary mechanical barrier preventing adhesion formation.
4DryField® PH does not contain any components of animal or human origin. It is biocompatible, free of pyrogens and allergens.
Side effects have not been reported.