Trial Outcomes & Findings for Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis (NCT NCT02664220)
NCT ID: NCT02664220
Last Updated: 2019-04-17
Results Overview
30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
30 days post surgery
Results posted on
2019-04-17
Participant Flow
Of 372 subjects consented, 100 were enrolled as these subjects had perforated appendicities
Participant milestones
| Measure |
Povidone-iodine Irrigation
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
No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Baseline characteristics by cohort
| Measure |
Povidone-iodine Irrigation
n=50 Participants
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
n=50 Participants
No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.4 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
10.6 years
STANDARD_DEVIATION 4 • n=7 Participants
|
10.4 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post surgery30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
Outcome measures
| Measure |
Povidone-iodine Irrigation
n=50 Participants
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
n=50 Participants
No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
|
|---|---|---|
|
Number of Participants With Postoperative Intra-abdominal Abscess
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 days post surgeryTotal hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days.
Outcome measures
| Measure |
Povidone-iodine Irrigation
n=50 Participants
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
n=50 Participants
No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
|
|---|---|---|
|
Total Hospital Length of Stay
|
5.1 days
Standard Deviation 2.4
|
6.1 days
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 30 days post surgeryWhether 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.
Outcome measures
| Measure |
Povidone-iodine Irrigation
n=50 Participants
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
n=50 Participants
No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
|
|---|---|---|
|
Number of Participants Who Were Readmitted to the Hospital
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days post surgeryWhether 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.
Outcome measures
| Measure |
Povidone-iodine Irrigation
n=50 Participants
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
n=50 Participants
No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
|
|---|---|---|
|
Number of Participants Who Visited the Emergency Room
|
3 Participants
|
7 Participants
|
Adverse Events
Povidone-iodine Irrigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Irrigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kuojen Tsao
McGovern Medical School, University of Texas Health Sciences Center at Houston
Phone: 713-500-7300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place