[Evaluation of the efficacy of a new generation of hemostatic collagen compresses. Results of a multicenter prospective study in visceral surgery and neurosurgery].
The hemostatic potential, tolerance and handiness of a new generation of hemostatic sheets (Hemostagene) were compared with those of reference collagen sheets in a randomized parallel-group multicenter study. Both types of hemostatic sheets, issued from calf derm, have been evaluated in digestive and neurosurgical pathologies. The comparability of both groups (52 patients in the Hemostagene group A, 54 in the reference group B) has been verified on morphological data, coagulation records and hemostasis conditions. The time required to achieve hemostasis was slightly, yet not significantly, shorter in group A (3 min 27 sec) than with the reference sheet (4 min 10 sec). This new sheet was judged significantly handier than the reference sheet. Adherence to the gloves and instruments was very significantly (p less than 0.0001) more frequent in the reference group B than in the group A. Both collagen sheets have quite similar clinical, biological and immunological tolerances which confirms the literature data. So, this new sheet, together with an hemostasis at least as good as the one obtained with the reference sheet, brings a highly improved handiness.
Frileux
P
P
Service de Chirurgie Générale et Digestive, Hôpital Laënnec, Paris.
Boutelier
P
P
Parc
R
R
Peix
J L
JL
Thiebaut
J B
JB
D001458:Bandages; D003094:Collagen / Q000009:adverse effects / Q000737:chemistry*; D004066:Digestive System Diseases / Q000601:surgery; D005260:Female; D006489:Hemostatic Techniques; D006801:Humans; D008297:Male; D009422:Nervous System Diseases / Q000601:surgery; D011446:Prospective Studies; D015503:Surgical Sponges
D003094:Collagen
Evaluation de l'efficacité d'une nouvelle génération de compresses hémostatiques de collagène. Résultats d'une étude prospective multicentrique en chirurgie viscérale et neurochirurgie.