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Direct Resuscitation of the Open Peritoneum (SH DROP)

Primary Purpose

Wound; Abdomen, Abdomen, Acute, Wound Surgical

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abthera™ Open Abdomen Negative Pressure Therapy Device System
Dianeal PD-2 with 2.5% Dextrose
Sponsored by
Sanford Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound; Abdomen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥18 years of age
  • Have index operation performed by one of the Trauma and Acute Care surgeons at Sanford Medical Center Fargo
  • Require an open abdomen due to a non-traumatic cause and placement of an Abthera™ wound vacuum
  • Cognitively impaired adults will be included if a Legally Authorized Representative is available to provide informed consent.

Exclusion Criteria:

  • Patients under the age of 18
  • Vulnerable populations such as pregnant women and prisoners
  • Patients with open abdomens as the result of trauma
  • Non-English speaking (Due to time constraints pre-operatively and the length of time necessary to secure translation services, non-English speaking patients will not be enrolled).

Sites / Locations

  • Sanford Medical Center FargoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Negative Wound Pressure Therapy

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Arm Description

Negative Pressure Would Therapy

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Outcomes

Primary Outcome Measures

Major Complications
Major complications (yes/no). Major complications include intra-abdominal abscess, wound dehiscence, anastomotic leak, intra-abdominal bleed, biloma, enterocutaneous fistula, evisceration, acute respiratory distress syndrome (ARDS)
Number of operations and time to closure
how many procedures/how long did it take to close the abdomen

Secondary Outcome Measures

Length of ICU Stay
How many days was patient in ICU
Time on Vasopressors
How many days was patient on vasopressors

Full Information

First Posted
May 5, 2021
Last Updated
July 13, 2022
Sponsor
Sanford Health
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1. Study Identification

Unique Protocol Identification Number
NCT04887480
Brief Title
Direct Resuscitation of the Open Peritoneum
Acronym
SH DROP
Official Title
Direct Resuscitation of the Open Peritoneum: A Randomized Controlled Trial in Non-Traumatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanford Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound; Abdomen, Abdomen, Acute, Wound Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negative Wound Pressure Therapy
Arm Type
Active Comparator
Arm Description
Negative Pressure Would Therapy
Arm Title
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
Arm Type
Active Comparator
Arm Description
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
Intervention Type
Device
Intervention Name(s)
Abthera™ Open Abdomen Negative Pressure Therapy Device System
Intervention Description
Suction set at -125mmHg
Intervention Type
Drug
Intervention Name(s)
Dianeal PD-2 with 2.5% Dextrose
Intervention Description
800mL to 1000mL of Dianeal PD-2 into Abthera™ and dwell for 1 hour.
Primary Outcome Measure Information:
Title
Major Complications
Description
Major complications (yes/no). Major complications include intra-abdominal abscess, wound dehiscence, anastomotic leak, intra-abdominal bleed, biloma, enterocutaneous fistula, evisceration, acute respiratory distress syndrome (ARDS)
Time Frame
Through study completion, an average of 6 months
Title
Number of operations and time to closure
Description
how many procedures/how long did it take to close the abdomen
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Length of ICU Stay
Description
How many days was patient in ICU
Time Frame
up to 4 weeks
Title
Time on Vasopressors
Description
How many days was patient on vasopressors
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years of age Have index operation performed by one of the Trauma and Acute Care surgeons at Sanford Medical Center Fargo Require an open abdomen due to a non-traumatic cause and placement of an Abthera™ wound vacuum Cognitively impaired adults will be included if a Legally Authorized Representative is available to provide informed consent. Exclusion Criteria: Patients under the age of 18 Vulnerable populations such as pregnant women and prisoners Patients with open abdomens as the result of trauma Non-English speaking (Due to time constraints pre-operatively and the length of time necessary to secure translation services, non-English speaking patients will not be enrolled).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawna S Differding
Phone
701-417-2002
Email
Shawna.Differding@SanfordHealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Maul
Phone
701-417-2004
Email
Lara.Maul@SanfordHealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mentor Ahmeti, MD
Organizational Affiliation
Sanford Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford Medical Center Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawna S Differding
Phone
701-417-2002
Email
Shawna.Differding@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Mentor Ahmeti, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Direct Resuscitation of the Open Peritoneum

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