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Direct Peritoneal Resuscitation for Acute Abdomen (SH DROP Trial)
N/A
Waitlist Available
Led By Mentor Ahmeti, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Require an open abdomen due to a non-traumatic cause and placement of an Abthera™ wound vacuum
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
SH DROP Trial Summary
This trial is testing whether adding dialysis fluid to the abdomen before suctioning it out can lower the risk of complications and death, and allow the surgeon to close the abdomen sooner.
Who is the study for?
The DROP trial is for adults over 18 who've had abdominal surgery at Sanford Medical Center Fargo and need their abdomen left open, using an Abthera™ wound vacuum. It includes those with cognitive impairments if they have a legal representative for consent. Excluded are minors, pregnant women, prisoners, trauma patients, and non-English speakers.Check my eligibility
What is being tested?
This study compares the standard sterile dressing connected to a vacuum (which removes fluid) against adding dialysis fluid into the abdomen before suctioning it out. The goal is to see if this method reduces complications and death rates while allowing faster closure of the abdomen.See study design
What are the potential side effects?
Potential side effects may include discomfort from the added dialysis fluid process or issues related to negative pressure therapy such as skin irritation or infection around the wound site.
SH DROP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a condition that requires your abdomen to be open and a specific wound vacuum to be placed.
SH DROP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Complications
Number of operations and time to closure
Secondary outcome measures
Length of ICU Stay
Time on Vasopressors
SH DROP Trial Design
2Treatment groups
Active Control
Group I: Negative Wound Pressure TherapyActive Control1 Intervention
Negative Pressure Would Therapy
Group II: Negative Wound Pressure Therapy with Direct Peritoneal ResuscitationActive Control2 Interventions
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
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Who is running the clinical trial?
Sanford HealthLead Sponsor
48 Previous Clinical Trials
61,723 Total Patients Enrolled
Mentor Ahmeti, MDPrincipal InvestigatorSanford Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a surgical wound in your abdomen that is still healing.You have a condition that requires your abdomen to be open and a specific wound vacuum to be placed.
Research Study Groups:
This trial has the following groups:- Group 1: Negative Wound Pressure Therapy
- Group 2: Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enrolled in this clinical trial?
"Absolutely. According to clinicaltrials.gov, this experiment was posted on May 14th 2021 and is seeking participants right now - the last update was made July 13th 2022. The research centre requires 200 individuals from 1 site to be enrolled in the study."
Answered by AI
Are researchers actively recruiting participants for this endeavor?
"Affirmative. According to clinicaltrials.gov, this study was initially published on May 14th 2021 and updated most recently on July 13th 2022. Recruitment is underway for 200 patients at 1 medical centre."
Answered by AI
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