Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
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|ClinicalTrials.gov Identifier: NCT02664220|
Recruitment Status : Completed
First Posted : January 26, 2016
Results First Posted : April 17, 2019
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute, Perforated Appendicitis||Drug: Povidone-iodine irrigation Procedure: No irrigation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Pilot Trial of Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
|Experimental: Povidone-iodine irrigation||
Drug: Povidone-iodine irrigation
Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.
1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister.
|Active Comparator: No irrigation||
Procedure: No irrigation
Patients allocated to the control group will not undergo intra-abdominal irrigation.
- Number of Participants With Postoperative Intra-abdominal Abscess [ Time Frame: 30 days post surgery ]30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
- Total Hospital Length of Stay [ Time Frame: 30 days post surgery ]Total hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days.
- Number of Participants Who Were Readmitted to the Hospital [ Time Frame: 30 days post surgery ]Whether or not a patient was readmitted to the hospital within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.
- Number of Participants Who Visited the Emergency Room [ Time Frame: 30 days post surgery ]Whether or not a patient visited the emergency room for care directly related to the operation within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.
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): NCT02664220
|United States, Texas|
|The University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||KuoJen Tsao, MD||The University of Texas Health Science Center, Houston|