Surgical Site Infections Clinical Trial
Official title:
Single Center, Open Label, Controlled Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole Tablets in Pelvi-abdominal Infections and Following IV Antibiotics in Post-operative Period
This study aims to assess the safety & efficacy of Oral Ciprodiazole® versus currently used Ciprofloxacin Tablets & Metronidazole tablets in pelvi-abdominal infections and following IV antibiotics in post-operative period, for pelvi-abdominal surgeries or acute conditions
Primary Objective 1. Primary Safety: To compare safety of oral Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets & Metronidazole tablets for pelvi-abdominal infections, either non-operative or post-operative following IV antibiotics. 2. Primary Efficacy: To compare efficacy of oral Ciprodiazole ® tablets (Ciprofolxacin/Metronidazole) versus currently used Ciprofloxacin Tablets & Metronidazole tablets for pelvi-abdominal infections, either non-operative or post-operative following IV antibiotics. Secondary Objective 1. Secondary Safety: - Presence of any signs/symptoms of post-operative wound infection such as redness, fever or wound discharge. - Presence of undesirable effects on total leukocyte count and liver enzymes (SGOT& SGPT) 2. Secondary Efficacy: - To compare the complete resolution or improvement of Pelvi-abdominal infection between ciprodiazole® versus combined treatment, based on pelvi-abdominal ultrasound and others - To compare the days for complete healing of post-operative wounds between ciprodiazole® versus combined treatment STUDY DURATION: - Subjects will be enrolled for 12 months including screening visit - Follow up for 15 days from enrolment STUDY POPULATION: 312 Egyptian Patients with pelvi-abdominal infection or started IV antibiotics in post-operative period, for pelvi - abdominal surgeries and/or acute conditions ASSESSMENT SCHEDULE: Subjects will be enrolled for 12 months including screening visit - Visit 1: Screening and treatment initiation visit, Day 0 - Follow-up 1 visit: Day 8 (+/-) 3 days - Follow-up 2 visit & End of study visit: Day 15 (+/-) 3 days ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04969302 -
Examination of the Effect of Skin Antisepsis With Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study
|
N/A | |
Completed |
NCT02253069 -
PHMB-based Antiseptic Use in Full-thickness Surgical Wounds
|
N/A | |
Completed |
NCT01472549 -
The Skin Prep Study
|
N/A | |
Completed |
NCT03685604 -
PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site
|
Phase 4 | |
Not yet recruiting |
NCT02503904 -
Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection
|
Phase 2/Phase 3 | |
Completed |
NCT01888367 -
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
|
Phase 2 | |
Completed |
NCT02619773 -
Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery
|
N/A | |
Completed |
NCT01425697 -
Eliminate Risk of Cardiac Surgical Site Events
|
N/A | |
Terminated |
NCT02799667 -
Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery
|
N/A | |
Recruiting |
NCT02436395 -
Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs
|
N/A | |
Active, not recruiting |
NCT03402945 -
Prevention of Infections in Cardiac Surgery (PICS) Prevena Study
|
Phase 4 | |
Withdrawn |
NCT02666365 -
Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair
|
Phase 4 | |
Completed |
NCT01971138 -
Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines
|
N/A | |
Completed |
NCT01949935 -
Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting
|
Phase 3 | |
Completed |
NCT01138852 -
Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
|
Phase 4 | |
Recruiting |
NCT06378359 -
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
|
||
Not yet recruiting |
NCT02012517 -
Antibiotic Prophylaxis in Prosthetic Breast Reconstructions
|
Phase 4 | |
Completed |
NCT01916733 -
A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Insulin Study
|
N/A | |
Completed |
NCT03686553 -
St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections
|
||
Not yet recruiting |
NCT06043414 -
Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT
|
N/A |