Antibiotikaprofylakse ved vaginalplastik

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Product Name: cefuroxim Product Code: 436485 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: cefuroxim Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1500‐ CONDITION: Uterine prolapse grade I‐II, cystocele and/or rectocele and/or enterocele grade I ‐ IV and/or defects of the perineal body where there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy. ICD10 codes: N81.1 ‐ N81.8 PRIMARY OUTCOME: Main Objective: Primary endpoint is : no infections (urinary tract infections, pneumonia, wound infections, infected haematomas etc) within 30 days postoperatively. Primary end point(s): No diagnosed infections (urinary tract infections, pneumonia, wound infections, infected haematomas etc) 30 days postoperatively. Secondary Objective: INCLUSION CRITERIA: Women age +18 with uterine prolapse grade I‐II and/or cystocele and/or rectocele and/or enterocele grade I ‐ IV and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: fea303cf9880a66fa4b114be0e4eea9308437a75
First added on: Aug 21, 2024