The authors present the data obtained from clinical research carried out in order to verify the efficacy of a long-term complete reabsorbable suture in Vascular Surgery. After a preliminary animal trial to test directly the theoretical basis of their study, they started the research using the double blind technique and attempting the rules of 18° World Medical Assembly at Helsinki. Two-hundred-twenty-nine patients were entered comparing the vascular sutures made by Maxon® CV to Prolene®, this one is supposed to be the reference gold standard for vascular surgery use. The needle and the caliber of the two types of suture were as similar as possible. The research field was the same as used to deal with both in elective and emergency situations. It was mandatory not to use the suture with synthetic graft anastomoses. Three different groups were identified: Peripheral arterial obstructive disease on the clinical stage of 'claudicatio intermittens' (Fontaine's stage 2 in very selected cases), rest pain and gangrene (Fontaine's stage 3 and 4). In these two groups homologous venous grafts were used. The third group is represented by patients operated upon for carotid TEA or direct arterial/venous suture without using graft of any kind. The study took about 2 years, between June 1988 and May 1990. The data proved the real efficacy of the absorbable suture, no substantial difference with the comparative one and a lower tendency to produce a neointimal proliferation (fibromyoplasia) for the absorbable sutures. Theoretically supposed complications such as suture disruption, aneurysmal or pseudoaneurysmal tendency, in other words complications linked with suture disappearance, never happened.
La sutura riassorbibile in chirurgia vascolare. Ricerca clinica comparativa
MASCOLI, Francesco
Primo
;OCCHIONORELLI, SavinoSecondo
;VASQUEZ, Giorgio;A. DONINI;CARCOFORO, Paolo;GASBARRO, Vincenzo;RUBBINI, Michele;POZZA, Enzo;E. GRESTAPenultimo
;I. DONINIUltimo
1994
Abstract
The authors present the data obtained from clinical research carried out in order to verify the efficacy of a long-term complete reabsorbable suture in Vascular Surgery. After a preliminary animal trial to test directly the theoretical basis of their study, they started the research using the double blind technique and attempting the rules of 18° World Medical Assembly at Helsinki. Two-hundred-twenty-nine patients were entered comparing the vascular sutures made by Maxon® CV to Prolene®, this one is supposed to be the reference gold standard for vascular surgery use. The needle and the caliber of the two types of suture were as similar as possible. The research field was the same as used to deal with both in elective and emergency situations. It was mandatory not to use the suture with synthetic graft anastomoses. Three different groups were identified: Peripheral arterial obstructive disease on the clinical stage of 'claudicatio intermittens' (Fontaine's stage 2 in very selected cases), rest pain and gangrene (Fontaine's stage 3 and 4). In these two groups homologous venous grafts were used. The third group is represented by patients operated upon for carotid TEA or direct arterial/venous suture without using graft of any kind. The study took about 2 years, between June 1988 and May 1990. The data proved the real efficacy of the absorbable suture, no substantial difference with the comparative one and a lower tendency to produce a neointimal proliferation (fibromyoplasia) for the absorbable sutures. Theoretically supposed complications such as suture disruption, aneurysmal or pseudoaneurysmal tendency, in other words complications linked with suture disappearance, never happened.File | Dimensione | Formato | |
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