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Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis (PA protocol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039750
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Prisma Health-Upstate

Brief Summary:
The proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and IAA in perforated appendicitis compared to suction without irrigation. This will be the first prospective study to compare these two options in pediatric PA.

Condition or disease Intervention/treatment Phase
Perforated Appendicitis Drug: antibiotic rinse with suction Procedure: suction only Phase 2

Detailed Description:

This study is for pediatric patients who are having an appendectomy and have a perforated appendix. The purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity.

Arm A patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. Arm B patients will not have the antibiotic irrigation but will have their wound suctioned.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized into 1 of 2 groups. Group "A" will be Antibiotic Irrigation with suction and Group "B" will be Suction Alone.
Masking: Single (Participant)
Masking Description: there is no masking after randomization
Primary Purpose: Treatment
Official Title: Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antibiotic irrigation with suction
Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery
Drug: antibiotic rinse with suction
antibiotic rinse with suction
Other Name: Clindamycin, gentamycin

Active Comparator: suction only
Group B: You will receive suction alone if a PA is found during surgery
Procedure: suction only
no irrigation, suction only




Primary Outcome Measures :
  1. wound complications [ Time Frame: 30 days ]
    The overall objective is to change the postoperative wound complications and IAA after laparoscopic appendectomy for perforated appendicitis in pediatric patients. The outcome will be measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, age 18 years or younger
  2. Scheduled to undergo laparoscopic appendectomy
  3. Preoperative or intra-operative diagnosis of perforated appendicitis (PA).
  4. Willingness to undergo treatments, provide written informed consent, and participate in follow-up.

Exclusion Criteria:

  1. Male or female older than 18 years of age
  2. Declined to undergo laparoscopic appendectomy
  3. Not willing to provide written informed consent or undergo randomization of treatment
  4. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039750


Contacts
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Contact: Robert Gates, MD 864-797-7400 robert.gates@prismahealth.org
Contact: Sharon Haire, NP 864-797-7400

Locations
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United States, South Carolina
Prisma Health - Upstate Recruiting
Greenville, South Carolina, United States, 29615
Contact: Robert Gates, MD    864-797-7400      
Contact: Sharon Haire, NP    864-797-7400      
Sponsors and Collaborators
Prisma Health-Upstate
Investigators
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Principal Investigator: Robert Gates, MD Prisma Health
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Responsible Party: Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT04039750    
Other Study ID Numbers: Pro00088360
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Appendicitis
Wound Infection
Infection
Intraabdominal Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Clindamycin
Gentamicins
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action