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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Acute, Perforated Appendicitis
Interventions Drug: Povidone-iodine irrigation
Procedure: No irrigation
Enrollment 100
Recruitment Details Of 372 subjects consented, 100 were enrolled as these subjects had perforated appendicities
Pre-assignment Details  
Arm/Group Title Povidone-iodine Irrigation No Irrigation
Hide Arm/Group Description

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.

No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Povidone-iodine Irrigation No Irrigation Total
Hide Arm/Group Description

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.

No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
50
 100.0%
50
 100.0%
100
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
10.4  (3.6) 10.6  (4) 10.4  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
18
  36.0%
22
  44.0%
40
  40.0%
Male
32
  64.0%
28
  56.0%
60
  60.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
White
8
  16.0%
11
  22.0%
19
  19.0%
Hispanic
29
  58.0%
28
  56.0%
57
  57.0%
Black
5
  10.0%
4
   8.0%
9
   9.0%
Asian
2
   4.0%
0
   0.0%
2
   2.0%
Other/Unknown
6
  12.0%
7
  14.0%
13
  13.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50
 100.0%
50
 100.0%
100
 100.0%
1.Primary Outcome
Title Number of Participants With Postoperative Intra-abdominal Abscess
Hide Description 30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
Time Frame 30 days post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Povidone-iodine Irrigation No Irrigation
Hide Arm/Group Description:

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.

No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
6
  12.0%
8
  16.0%
2.Secondary Outcome
Title Total Hospital Length of Stay
Hide Description Total hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days.
Time Frame 30 days post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Povidone-iodine Irrigation No Irrigation
Hide Arm/Group Description:

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.

No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: days
5.1  (2.4) 6.1  (3.3)
3.Secondary Outcome
Title Number of Participants Who Were Readmitted to the Hospital
Hide Description 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.
Time Frame 30 days post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Povidone-iodine Irrigation No Irrigation
Hide Arm/Group Description:

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.

No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
   6.0%
4.Secondary Outcome
Title Number of Participants Who Visited the Emergency Room
Hide Description 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.
Time Frame 30 days post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Povidone-iodine Irrigation No Irrigation
Hide Arm/Group Description:

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.

No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
3
   6.0%
7
  14.0%
Time Frame 30 days post surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Povidone-iodine Irrigation No Irrigation
Hide Arm/Group Description

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.

No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
All-Cause Mortality
Povidone-iodine Irrigation No Irrigation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Serious Adverse Events
Povidone-iodine Irrigation No Irrigation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Povidone-iodine Irrigation No Irrigation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kuojen Tsao
Organization: McGovern Medical School, University of Texas Health Sciences Center at Houston
Phone: 713-500-7300
EMail: Kuojen.Tsao@uth.tmc.edu
Layout table for additonal information
Responsible Party: KuoJen Tsao, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02664220    
Other Study ID Numbers: HSC-MS-15-1000
First Submitted: December 21, 2015
First Posted: January 26, 2016
Results First Submitted: March 6, 2019
Results First Posted: April 17, 2019
Last Update Posted: April 17, 2019