OBJECTIVE: The purpose of this study was to assess and compare inflammatory reactions to two types of sealed vascular prostheses used in the repair of abdominal aortic aneurysm. EXPERIMENTAL DESIGN: Randomized prospective study with a follow-up period of 21 days. SETTING: University hospital study. PATIENTS: Sixty patients admitted for elective abdominal aortic aneurysm repair. INTERVENTION: Each patient underwent repair of abdominal aortic aneurysm with either a gelatin-sealed knitted Dacron prosthesis (Gelseal, Vascutek, n = 30) or a collagen-sealed woven Dacron prosthesis (Hemashield, Meadox Medicals, n = 30). MEASURES: As indicators of the presence of inflammation, the peripheral blood cell count, platelet count, and plasma C-reactive protein (CRP) concentration were determined in each patient on postoperative days (PODs) 1, 7, 14 and 21. Body temperature was measured every 8 hours. RESULTS: Patients in both groups revealed a low-grade fever and leukocytosis during the first 7 PODs. Significantly higher leukocyte counts were demonstrated in the Gelseal group on PODs 7 and 14. However, no difference in the leukocyte count, CRP concentration, or body temperature existed between the two groups on POD 21. Biphasis changes in the platelet count were observed in both groups. No complications were encountered. CONCLUSION: The Gelseal prosthesis was associated with higher inflammatory response during the second week following implantation, but this difference had resolved by POD 21. This finding may reflect an inflammatory reaction against impregnated gelatin.
RCT Entities:
OBJECTIVE: The purpose of this study was to assess and compare inflammatory reactions to two types of sealed vascular prostheses used in the repair of abdominal aortic aneurysm. EXPERIMENTAL DESIGN: Randomized prospective study with a follow-up period of 21 days. SETTING: University hospital study. PATIENTS: Sixty patients admitted for elective abdominal aortic aneurysm repair. INTERVENTION: Each patient underwent repair of abdominal aortic aneurysm with either a gelatin-sealed knitted Dacron prosthesis (Gelseal, Vascutek, n = 30) or a collagen-sealed woven Dacron prosthesis (Hemashield, Meadox Medicals, n = 30). MEASURES: As indicators of the presence of inflammation, the peripheral blood cell count, platelet count, and plasma C-reactive protein (CRP) concentration were determined in each patient on postoperative days (PODs) 1, 7, 14 and 21. Body temperature was measured every 8 hours. RESULTS:Patients in both groups revealed a low-grade fever and leukocytosis during the first 7 PODs. Significantly higher leukocyte counts were demonstrated in the Gelseal group on PODs 7 and 14. However, no difference in the leukocyte count, CRP concentration, or body temperature existed between the two groups on POD 21. Biphasis changes in the platelet count were observed in both groups. No complications were encountered. CONCLUSION: The Gelseal prosthesis was associated with higher inflammatory response during the second week following implantation, but this difference had resolved by POD 21. This finding may reflect an inflammatory reaction against impregnated gelatin.