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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic irrigation with suction | Experimental | Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery |
|
| suction only | Active Comparator | Group B: You will receive suction alone if a PA is found during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antibiotic rinse with suction | Drug | antibiotic rinse with suction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gates, MD | Prisma Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health - Upstate | Greenville | South Carolina | 29615 | United States |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D013396 | Suction |
| D002981 | Clindamycin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013514 | Surgical Procedures, Operative |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
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Patients will be randomized into 1 of 2 groups. Group "A" will be Antibiotic Irrigation with suction and Group "B" will be Suction Alone.
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there is no masking after randomization
| suction only | Procedure | no irrigation, suction only |
|
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000617 | Aminoglycosides |