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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
Sponsor:
Information provided by (Responsible Party):
KuoJen Tsao, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE January 26, 2016
Results First Submitted Date  ICMJE March 6, 2019
Results First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE April 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
Number of Participants With Postoperative Intra-abdominal Abscess [ Time Frame: 30 days post surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Official Title  ICMJE A Randomized Pilot Trial of Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Brief Summary The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis. Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal irrigation.
Detailed Description Postoperative intra-abdominal abscesses are common occurrences after perforated appendicitis in pediatric patients despite utilization of evidence-based practices. Povidone-iodine is a commonly used antiseptic in surgical procedures and has been shown to be effective in reducing postoperative abscesses in adults with perforated appendicitis. This trial will be the first to rigorously test the efficacy of povidone-iodine irrigation in children and to verify its safety profile in this patient population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Acute, Perforated Appendicitis
Intervention  ICMJE
  • 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.

  • Procedure: No irrigation
    Patients allocated to the control group will not undergo intra-abdominal irrigation.
Study Arms  ICMJE
  • Experimental: Povidone-iodine irrigation
    Intervention: Drug: Povidone-iodine irrigation
  • Active Comparator: No irrigation
    Intervention: Procedure: No irrigation
Publications * Anderson KT, Putnam LR, Bartz-Kurycki MA, Hamilton EC, Yafi M, Pedroza C, Austin MT, Kawaguchi AL, Kao LS, Lally KP, Tsao K. Povidone-iodine Irrigation for Pediatric Perforated Appendicitis May Be Protective: A Bayesian Pilot Randomized Controlled Trial. Ann Surg. 2020 May;271(5):827-833. doi: 10.1097/SLA.0000000000003398.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2016)
120
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children who undergo an appendectomy for perforated appendicitis. (Appendicitis: Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.)

Exclusion Criteria:

  • Patients presenting with simple or gangrenous appendicitis
  • Patients with a history of iodine sensitivity, thyroid disease or renal disease
  • Patients undergoing interval or incidental appendectomy
  • Patients/parents/legal guardians who are both non-English and non-Spanish speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02664220
Other Study ID Numbers  ICMJE HSC-MS-15-1000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KuoJen Tsao, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: KuoJen Tsao, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP