Antibiotic Irrigations for Intra-Abdominal Drains

Study Overview
=================
Brief Summary
-----------------
Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current standard of care includes drain placement in the abscess cavity to reach source control as well as administration of systemic antibiotics. It is common practice to flush the drain on a daily basis to ensure patency. This study aims to analyze the clinical impact of a higher local concentration of antibiotics (rather than normal saline) provided through drain irrigation with an antimicrobial agent (Gentamicin and/or Clindamycin) compare to normal saline.

Detailed Description
-----------------
People with an abdominal abscess who undergo drain placement will have those drains irrigated twice/day with either normal saline (placebo group) or with the above antibiotic solution for a total of 7 days or less if the drain were to be removed earlier. Outcomes of interest are duration of systemic antibiotics, and WBC and temperature curve.

Official Title
-----------------
Antibiotic Irrigations for Intra-Abdominal Drains

Conditions
-----------------
Abdominal Abscess

Intervention / Treatment
-----------------
* Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection
* Drug: Clindamycin phosphate 6 mg/1ml for injection
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intra-abdominal abscess drained with catheter/drain Treatment with systemic antibiotics Able to consent Exclusion Criteria: Abscess(es) not amendable for an image guided drain placement.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two group, study and control group. In control group, patient will receive standard intra-abdominal drain care with daily flushing of the drain with normal saline. In study group, patient will receive daily flush with antibiotic for 7 days.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic Irrigation<br>The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum | Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection<br>* Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.<br>Drug: Clindamycin phosphate 6 mg/1ml for injection<br>* Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.<br>|
| Placebo Comparator: Normal Saline Irrigation<br>The drain will be irrigated twice/day with normal saline | Other: Placebo<br>* The placebo group will receive drain irrigation twice/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of systemic antibiotics | Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention. | From initiation of systemic treatment until 1 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White Blood Count | White blood count level from the blood draw will be measured starting from the admission until discharge or discontinuation by primary care team. During follow up, if white blood count will be measured, will record up to 1 month follow up. The white blood count will be measured once daily and as needed depending on clinical changes. We will plan to trend WBC as another indication of decreasing systemic inflammation. | From initiation of systemic treatment until 1 month follow up | 
| Change in temperature | Temperature will be measured every 8 hours starting from admission and until patient discharge. And also temperature will be measured during each follow up clinic visit. Change in temperature is monitored as an indication of decrease systemic inflammation. | From initiation of systemic treatment until 1 month follow up | 
| Changes in size of the Abscess | CT scan of would have been obtained prior to image guided drain placement. Any subsequent CT scans up to 1 month follow up upon discharge will be reviewed to assess changes in size of the abscess. This will be monitored for assessing the effectiveness of intervention. | From patient initial hospitalization up to 1 month follow up | 
| Changes in Drain Output | Drain will have certain output that is recorded daily. Daily drain output will be in unit of ml and will be monitored as a measurement of abscess resolution. | From the drain placement up to 1 month follow up | 
| Duration of drain | The total duration of the drain placement will be recorded in days starting from the day of placement up to drain removal and monitored as a effectiveness of the intervention. | From the drain placement until 1 month follow up |