Antibiotic Irrigations for Intra-Abdominal Drains (AID)
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|ClinicalTrials.gov Identifier: NCT03476941|
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Abscess||Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection Drug: Clindamycin phosphate 6 mg/1ml for injection Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 Description:||Written consent will be obtained from all participants. Then, each participant will be randomized into two arms. Nurse will administer the drain flush either with normal saline or antibiotic irrigation.|
|Official Title:||Antibiotic Irrigations for Intra-Abdominal Drains|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
Experimental: Antibiotic Irrigation
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
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.
Drug: Clindamycin phosphate 6 mg/1ml for injection
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.
Placebo Comparator: Normal Saline Irrigation
The drain will be irrigated twice/day with normal saline
The placebo group will receive drain irrigation twice/day
- Duration of systemic antibiotics [ Time Frame: From initiation of systemic treatment until 1 month follow up ]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.
- White Blood Count [ Time Frame: From initiation of systemic treatment until 1 month follow up ]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.
- Change in temperature [ Time Frame: From initiation of systemic treatment until 1 month follow up ]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.
- Changes in size of the Abscess [ Time Frame: From patient initial hospitalization up to 1 month follow up ]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.
- Changes in Drain Output [ Time Frame: From the drain placement up to 1 month follow up ]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.
- Duration of drain [ Time Frame: From the drain placement until 1 month follow up ]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.
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): NCT03476941
|Contact: Thomas Granchi, MDemail@example.com|
|Contact: Linda Ahrensfirstname.lastname@example.org|
|United States, Iowa|
|The University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: John Keller 319-335-2123 email@example.com|
|Principal Investigator: Paolo Goffredo, MD|
|Sub-Investigator: Thomas Granchi, MD|
|Principal Investigator:||Paolo Goffredo, MD||University of Iowa|