Perforated Appendicitis
Conditions
Keywords
appendectomy
Brief summary
To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis
Detailed description
Appendicitis is the most common cause of abdominal pain requiring emergent surgical intervention in children and approximately one third of patients present with perforation. Perforated appendicitis has been demonstrated to have a significant impact on patients and families due to the prolonged hospitalization, high complication rates, and tremendous economic burden from treatment. The most significant complication following operative treatment of perforated appendicitis is intra-abdominal abscess, which develops in approximately 20% of children following appendectomy in recent literature. Due to this frequent and morbid complication, continued research has been driven at determining the most efficacious and cost-effective postoperative antibiotic treatment regimen to reduce post-operative abscess. As postoperative abscess rates following appendectomy for perforated appendicitis remain high, the primary aim of this study was to evaluate a new postoperative antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with randomization into ten day completion course of home antibiotics with IV ertapenem versus oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer reduced rates of postoperative abscess, with no major difference between completion courses of home IV versus oral antibiotics.
Interventions
DRUGhome intravenous ertapenem
see arm description
DRUGhome oral amoxicillin-clavulanate
see arm description
DEVICEperipheral inserted central Catheter
All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.
Exclusion criteria
* Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Abscess | Thirty days after appendectomy | Number of Postoperative Abscess, thirty-day postoperative |
| Number of Participants With Wound Infections | Thirty days following appendectomy | Number of Wound Infections, 30-days postoperative |
| Number Participants With Readmission Within 30 Days | Thirty days following appendectomy | Number of Readmission within 30 days postoperative |
| Hospital Charge | Thirty days following appendectomy | Cost of Hospital services |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home Intravenous Ertapenem and PICC Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics. | 44 |
| Home Oral Amoxicillin-clavulanate Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours). | 38 |
| Total | 82 |
Baseline characteristics
| Characteristic | Home Intravenous Ertapenem and PICC | Home Oral Amoxicillin-clavulanate | Total |
|---|---|---|---|
| Age, Continuous | 12.3 Years STANDARD_DEVIATION 3.6 | 10.1 Years STANDARD_DEVIATION 3.6 | 11.3 Years STANDARD_DEVIATION 3.7 |
| BMI | 20.9 kg/m^2 STANDARD_DEVIATION 5.8 | 17.9 kg/m^2 STANDARD_DEVIATION 3.5 | 19.5 kg/m^2 STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 17 Participants | 32 Participants |
| Race (NIH/OMB) White | 24 Participants | 19 Participants | 43 Participants |
| Region of Enrollment United States | 44 Participants | 38 Participants | 82 Participants |
| Sex: Female, Male Female | 23 Participants | 18 Participants | 41 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 38 |
| other Total, other adverse events | 0 / 44 | 0 / 38 |
| serious Total, serious adverse events | 0 / 44 | 2 / 38 |
Outcome results
Primary
Hospital Charge
Cost of Hospital services
Time frame: Thirty days following appendectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Intravenous Ertapenem and PICC | Hospital Charge | 47564.3 Dollars | Standard Deviation 9057.59 |
| Home Oral Amoxicillin-clavulanate | Hospital Charge | 34227.79 Dollars | Standard Deviation 8104.65 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
Number of Participants With Postoperative Abscess
Number of Postoperative Abscess, thirty-day postoperative
Time frame: Thirty days after appendectomy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Intravenous Ertapenem and PICC | Number of Participants With Postoperative Abscess | 5 Participants |
| Home Oral Amoxicillin-clavulanate | Number of Participants With Postoperative Abscess | 3 Participants |
p-value: 0.7188Chi-squared
Primary
Number of Participants With Wound Infections
Number of Wound Infections, 30-days postoperative
Time frame: Thirty days following appendectomy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Intravenous Ertapenem and PICC | Number of Participants With Wound Infections | 1 Participants |
| Home Oral Amoxicillin-clavulanate | Number of Participants With Wound Infections | 2 Participants |
p-value: 0.5933Chi-squared
Primary
Number Participants With Readmission Within 30 Days
Number of Readmission within 30 days postoperative
Time frame: Thirty days following appendectomy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Intravenous Ertapenem and PICC | Number Participants With Readmission Within 30 Days | 6 Participants |
| Home Oral Amoxicillin-clavulanate | Number Participants With Readmission Within 30 Days | 6 Participants |
p-value: >0.99Chi-squared