Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section
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|ClinicalTrials.gov Identifier: NCT03549702|
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Drug: Povidone iodine 1% solution||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section (Randomized Control Trial)|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||March 3, 2018|
Active Comparator: Povidone irrigation Group
Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
Drug: Povidone iodine 1% solution
irrigation of subcutaneous tissue with Povidone-Iodine prior to skin closure
No Intervention: Control Group
Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.
- Surgical site infection up to 14 days following elective caesarian section. [ Time Frame: 14 Days ]
- Infection involves only skin and subcutaneous tissue of this incision.
- Occurs within 14 days after the operative procedure.
Includes at least one of the following:
- purulent drainage is present (culture documentation not required)
- organisms are isolated from fluid/tissue of the superficial incision
- at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
- the wound is deliberately opened by the surgeon
- the surgeon or clinician declares the wound infected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549702
|Faculty of Medicine - Ain SHams University|
|Cairo, Egypt, 202|
|Principal Investigator:||George Azmy, MBBCH||Specialist of Obstetrics and Gynecology|