Acute, Perforated Appendicitis
Conditions
Keywords
Povidone-iodine irrigation
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.
Interventions
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.
PROCEDURENo irrigation
Patients allocated to the control group will not undergo intra-abdominal irrigation.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Intra-abdominal Abscess | 30 days post surgery | 30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Hospital Length of Stay | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Of 372 subjects consented, 100 were enrolled as these subjects had perforated appendicities
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| No Irrigation No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Povidone-iodine Irrigation | No Irrigation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.4 years STANDARD_DEVIATION 3.6 | 10.6 years STANDARD_DEVIATION 4 | 10.4 years STANDARD_DEVIATION 3.6 |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 29 Participants | 28 Participants | 57 Participants |
| Race/Ethnicity, Customized Other/Unknown | 6 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 11 Participants | 19 Participants |
| Region of Enrollment United States | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 18 Participants | 22 Participants | 40 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Number of Participants With Postoperative Intra-abdominal Abscess
30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
Time frame: 30 days post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine Irrigation | Number of Participants With Postoperative Intra-abdominal Abscess | 6 Participants |
| No Irrigation | Number of Participants With Postoperative Intra-abdominal Abscess | 8 Participants |
Secondary
Number of Participants Who Visited the Emergency Room
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine Irrigation | Number of Participants Who Visited the Emergency Room | 3 Participants |
| No Irrigation | Number of Participants Who Visited the Emergency Room | 7 Participants |
Secondary
Number of Participants Who Were Readmitted to the Hospital
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine Irrigation | Number of Participants Who Were Readmitted to the Hospital | 0 Participants |
| No Irrigation | Number of Participants Who Were Readmitted to the Hospital | 3 Participants |
Secondary
Total Hospital Length of Stay
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Povidone-iodine Irrigation | Total Hospital Length of Stay | 5.1 days | Standard Deviation 2.4 |
| No Irrigation | Total Hospital Length of Stay | 6.1 days | Standard Deviation 3.3 |