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Completed
NCT05611944
Irrigation and Suction Trial to Prevent SSI
Conditions: Surgical Site Infection, Diabete Mellitus, Abdominal Hysterectomy
Sex: Female
Ages: 41 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 300
Sponsor: King Edward Medical University
Location: Pakistan
Summary
The study will be conducted on women with risk factors for SSI assigned to gynecological surgery with an open abdominal approach.
The participants will be designated to either Irrigation and suction arm by bilateral drain insertion or the control arm by randomization through the parallel assignment.
The participants will be followed for the outcome for four days in the hospital and then at 4 weeks, 8 weeks and 12 weeks postoperatively.
The primary outcome measure will be the SSI rate.
Secondary outcomes will be signs of SSI, post-operative pain, other complications and patient satisfaction.
Eligibility Criteria
Inclusion Criteria:Diabetic patientsage above 40yearsBMI>25kg/m2assigned to hysterectomyfit for anaesthesiapatients with other medical disorders like hepatitis and hypertension will also be included in the study.Exclusion Criteria:a BMI of less than 25kg/m2a preoperative haemoglobin level of less than 10 g/dl.
Source: ClinicalTrials.gov (NCT05611944). StuddyBuddy aggregates publicly available trial information.