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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute, Perforated Appendicitis Drug: Povidone-iodine irrigation Procedure: No irrigation Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Appendicitis

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: KuoJen Tsao, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by KuoJen Tsao, The University of Texas Health Science Center, Houston:
Study Protocol and Statistical Analysis Plan  [PDF] August 29, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: KuoJen Tsao, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02664220    
Other Study ID Numbers: HSC-MS-15-1000
First Posted: January 26, 2016    Key Record Dates
Results First Posted: April 17, 2019
Last Update Posted: April 17, 2019
Last Verified: March 2019
Keywords provided by KuoJen Tsao, The University of Texas Health Science Center, Houston:
Povidone-iodine irrigation
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
 Intestinal Diseases
Povidone-Iodine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents