Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis

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

Tracking Information

• First Submitted Date: December 21, 2015
• First Posted Date: January 26, 2016
• Results First Submitted Date: March 6, 2019
• Results First Posted Date: April 17, 2019
• Last Update Posted Date: April 17, 2019
• Study Start Date: April 2016
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: January 21, 2016): Number of Participants With Postoperative Intra-abdominal Abscess [ Time Frame: 30 days post surgery ]

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Acute, Perforated Appendicitis

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2018): 100
• Original Estimated Enrollment (submitted: January 21, 2016): 120
• Actual Study Completion Date: March 2018
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 2 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02664220
• Other Study ID Numbers: HSC-MS-15-1000
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: KuoJen Tsao, The University of Texas Health Science Center, Houston
• Study Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Not Provided

Investigators

• 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