Wound; AbdomenSH DROPNCT04887480
Direct Resuscitation of the Open Peritoneum
A study testing Abthera™ Open Abdomen Negative Pressure Therapy Device System and Dianeal PD-2 with 2.5% Dextrose in people with Wound; Abdomen and Abdomen, Acute, run by Sanford Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound; Abdomen, Abdomen, Acute, Wound Surgical
- What is being tested?
- Abthera™ Open Abdomen Negative Pressure Therapy Device System and Dianeal PD-2 with 2.5% Dextrose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
About this study
Official title: Direct Resuscitation of the Open Peritoneum: A Randomized Controlled Trial in Non-Traumatic Patients
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
- Conditions
- Wound; Abdomen, Abdomen, Acute, Wound Surgical
- Being tested
- Abthera™ Open Abdomen Negative Pressure Therapy Device System, Dianeal PD-2 with 2.5% Dextrose
- Medical subject headings
- Abdominal Injuries, Abdomen, Acute, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abthera™ Open Abdomen Negative Pressure Therapy Device SystemDevice
Suction set at -125mmHg
Dianeal PD-2 with 2.5% DextroseDrug
800mL to 1000mL of Dianeal PD-2 into Abthera™ and dwell for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Negative Wound Pressure Therapy | Active comparator | Negative Pressure Would Therapy Receives: Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System |
| Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation | Active comparator | Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation Receives: Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System; Drug: Dianeal PD-2 with 2.5% Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, an average of 6 months
Number of operations and time to closure
how many procedures/how long did it take to close the abdomen
Measured: up to 4 weeks
Secondary outcomes (2)
Length of ICU Stay
How many days was patient in ICU
Measured: up to 4 weeks
Time on Vasopressors
How many days was patient on vasopressors
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start14 May 2021
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2026 (estimated)
Why it stopped: Funding paused
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound; AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mentor Ahmeti, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887480
- Sponsor's protocol ID
- SH Ahmeti DROP Study
- Acronym
- SH DROP
- Status last verified
- Jan 2024
- First submitted
- 5 May 2021
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Resuscitation of the Open Peritoneum: A Randomized Controlled Trial in Non-Traumatic Patients
- ClinicalTrials.gov ID
- NCT04887480
- Acronym / sponsor ID
- SH DROP / SH Ahmeti DROP Study
- Conditions
- Wound; Abdomen, Abdomen, Acute, Wound Surgical
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding paused
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Wound Pressure Therapy | Active comparator | Device: Abthera™ Open Abdomen Negative Pressure Therapy Device SystemNegative Pressure Would Therapy |
| Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation | Active comparator | Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System, Drug: Dianeal PD-2 with 2.5% DextroseNegative Wound Pressure Therapy with Direct Peritoneal Resuscitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abthera™ Open Abdomen Negative Pressure Therapy Device SystemSuction set at -125mmHg | Device | Negative Wound Pressure Therapy, Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation |
| Dianeal PD-2 with 2.5% Dextrose800mL to 1000mL of Dianeal PD-2 into Abthera™ and dwell for 1 hour. | Drug | Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation |
Primary outcome
Major Complications
Time frame: Through study completion, an average of 6 months
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
Time frame: up to 4 weeks
how many procedures/how long did it take to close the abdomen
2 secondary outcomes
Length of ICU Stay
Time frame: up to 4 weeks
Time on Vasopressors
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mentor Ahmeti, MD principal investigator
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abthera™ Open Abdomen Negative Pressure Therapy Device System and Dianeal PD-2 with 2.5% Dextrose in people with Wound; Abdomen and Abdomen, Acute, run by Sanford Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Complications (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.