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

Primary Purpose

Perforated Appendicitis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

antibiotic rinse with suction

suction only

About this trial

This is an interventional treatment trial for Perforated Appendicitis

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Prisma Health - UpstateRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antibiotic irrigation with suction

suction only

Arm Description

Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery

Group B: You will receive suction alone if a PA is found during surgery

Outcomes

Primary Outcome Measures

wound complications

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04039750

First Posted

July 26, 2019

Last Updated

January 17, 2023

Sponsor

Prisma Health-Upstate

1. Study Identification

Unique Protocol Identification Number

NCT04039750

Brief Title

Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis

Acronym

PA protocol

Official Title

Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 25, 2019 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Prisma Health-Upstate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perforated Appendicitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

there is no masking after randomization

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antibiotic irrigation with suction

Arm Type

Experimental

Arm Description

Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery

Arm Title

suction only

Arm Type

Active Comparator

Arm Description

Group B: You will receive suction alone if a PA is found during surgery

Intervention Type

Drug

Intervention Name(s)

antibiotic rinse with suction

Other Intervention Name(s)

Clindamycin, gentamycin

Intervention Description

antibiotic rinse with suction

Intervention Type

Procedure

Intervention Name(s)

suction only

Intervention Description

no irrigation, suction only

Primary Outcome Measure Information:

Title

wound complications

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age 18 years or younger Scheduled to undergo laparoscopic appendectomy Preoperative or intra-operative diagnosis of perforated appendicitis (PA). Willingness to undergo treatments, provide written informed consent, and participate in follow-up. Exclusion Criteria: Male or female older than 18 years of age Declined to undergo laparoscopic appendectomy Not willing to provide written informed consent or undergo randomization of treatment Pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Gates, MD

Phone

864-797-7400

robert.gates@prismahealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Sharon Haire, NP

Phone

864-797-7400

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Gates, MD

Organizational Affiliation

Prisma Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prisma Health - Upstate

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Gates, MD

Phone

864-797-7400

First Name & Middle Initial & Last Name & Degree

Sharon Haire, NP

Phone

864-797-7400

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis

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