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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perforated Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized into 1 of 2 groups. Group "A" will be Antibiotic Irrigation with suction and Group "B" will be Suction Alone.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

there is no masking after randomization

Study Groups

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Antibiotic irrigation with suction

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

Group Type EXPERIMENTAL

antibiotic rinse with suction

Intervention Type DRUG

antibiotic rinse with suction

suction only

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

Group Type ACTIVE_COMPARATOR

suction only

Intervention Type PROCEDURE

no irrigation, suction only

Interventions

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antibiotic rinse with suction

Intervention Type DRUG

suction only

no irrigation, suction only

Intervention Type PROCEDURE

Other Intervention Names

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Clindamycin, gentamycin

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No