Clinical trial

Antibiotic Instillation in Acute Complex Appendicitis for Prevention of Deep Space Surgical Site Infections

Name

IRB00323208

Description

Appendicitis (inflammation of the wall of the appendix, causing pain and tenderness in the abdomen) has a range of severity that goes from simple to complicated. Complicated appendicitis may present with infected fluid inside of the abdomen or a perforation or hole in the intestines. This research is being done to determine if placing an antibiotic solution in the abdomen at the time the appendix is removed is a safe procedure in patients between the ages of 3 and 18 years old with findings of complicated appendicitis. Johns Hopkins All Children's Hospital (JHACH)'s current standard of care for patients with complicated appendicitis includes suctioning the infected fluid out of the abdomen at the time the appendix is removed. As part of this study, the investigators would like to see if patients with complicated appendicitis will benefit from routine care plus leaving an antibiotic solution inside the abdomen, after fully suctioning the infected fluid out of the abdomen.

Trial arms

Trial start

2023-01-05

Estimated PCD

2024-02-02

Trial end

2024-03-20

Status

Completed

Phase

Early phase I

Treatment

Ceftriaxone

Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration. Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation. Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.

Arms:

Standard of Care and Antibiotic instillation (Arm B)

Other names:

Ceftriaxone sodium

Intra-peritoneal Fluid Aspiration

Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.

Arms:

Standard of Care (Arm A), Standard of Care and Antibiotic instillation (Arm B)

Size

Primary endpoint

Feasibility of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Percentage of Eligible Participants Who Agree to Participate

Up to 30 days postoperatively

Feasibility of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Percentage of Eligible Participants Who Complete All Intervention Sessions and Measurement Time Points

Up to 30 days postoperatively

Safety of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Number of Adverse Events

Up to 30 days postoperatively

Eligibility criteria

Inclusion Criteria: * Diagnosed with acute appendicitis and are scheduled to undergo urgent appendectomy * Between 3-18 years of age at time of appendectomy * Has intraoperative findings of complex appendicitis defined by: visible hole in the appendix, extra-luminal fecalith, diffuse fibropurulent exudate outside the RLQ/pelvis, or intraperitoneal abscess * Weighs equal to or greater than 20kg at time of surgery Exclusion Criteria: * Pregnant * Has a penicillin or cephalosporin allergy that is severe or anaphylactic in nature, prohibiting the use of these antibiotics * Has simple appendicitis * Undergoes appendectomy following failed or planned medical management of appendicitis * Has impaired renal function (CrCl \<15mL/min) * Has history of neurological conditions such as encephalopathy, seizures, myoclonus and non-convulsive status epilepticus * Has a known inability to complete a 30-day postoperative follow up

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-blinded randomized controlled pilot phase 2 study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "The surgeon and team administering the treatment will not be blinded; however, patients, patients' families, and hospital caregivers outside of the operating room will be blinded to the treatment.", 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2024-04-04

1 organization

Organization

Johns Hopkins All Children's Hospital