Open Abdomen After Damage Control LaparotomyNCT02297659
Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure
A study testing Primary Fascial Closure and wound vac dressing application in people with Open Abdomen After Damage Control Laparotomy, run by San Antonio Military Medical Center at 1 site in United States.
Trial summary
Damage control laparotomy (DCL) has proven to be a successful means to improve survival in severely injured patients.1-5 However, the consequences of not being able to close the fascia after the initial operation due to significant resuscitation leading to bowel and retroperitoneal edema, abdominal compartment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Abdomen After Damage Control Laparotomy
- What is being tested?
- Primary Fascial Closure and wound vac dressing application
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jan 2017
- 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
- All admissions of trauma patients who sustain trauma necessitating damage control laparotomy.
- Male and female patients 18 years or older.
Who cannot join
- Children (<18 years old), prisoners, or pregnant patients.
- Patients who have more than 1/3 loss of abdominal wall due to trauma.
- Patients with baseline serum sodium of <120 mEq/L or >155 mEq/L.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Antonio Military Medical Center
San Antonio, Texas, 78234
Valerie G Sams, MD, 859-230-0417, valerie.g.sams.mil@mail.mil
Michelle F Buehner, MD, michelle.f.buehner.mil@mail.mil
About this study
Damage control laparotomy (DCL) has proven to be a successful means to improve survival in severely injured patients.1-5 However, the consequences of not being able to close the fascia after the initial operation due to significant resuscitation leading to bowel and retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC) contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias, enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or standard crystalloid solutions after DCL and compare the time to PFC, rate of successful closure, and rate of complications associated with an open abdomen. The current failure rate of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using hypertonic saline.
Read the detailed description
The use of HTS after DCL may decrease the rate of failure to achieve PFC and reduce the number of complications associated with an open abdomen.
Research Questions:
- Primary Objective: Is there a higher rate of PFC among patients who undergo DCL and temporary abdominal closure when using HTS versus standard crystalloid resuscitation?
- Secondary Objectives: Does successful and faster PFC reduce ICU, ventilator and hospital days?
- Does faster and more successful PFC result in lower morbidity to include enterocutaneous fistula (ECF), intra-abdominal abscess (IAA), abdominal wall hernia, and anastomotic failure?
DCL is a common procedure wounded warriors undergo due to blast and other blunt and penetrating mechanisms of injury. This results in a significant population of warriors at risk for all of the complications and comorbidities that accompany an open abdomen. Thus, finding ways to not only achieve PFC but also to decrease the time to PFC will reduce these unwanted events.
The protocol design is a multi-institutional, prospective, double blind, randomized controlled trial of patients who undergo DCL for abdominal trauma requiring temporary abdominal closure and return to operating room for definitive treatment. All participating facilities are Level I Trauma Centers. Currently, the standard of care for damage control resuscitation involves all intravenous fluid solutions utilized in this study; normal saline, Ringer's lactate, Plasmalyte, and 3% saline (HTS). However, the type of fluid is selected based on surgeon preference alone. Investigators will randomize patients to normal saline at a resuscitation rate of 30 cc/hr or to 3% saline (HTS) at a resuscitation rate of 30cc/hr which will be initiated upon arrival to the ICU.
- Being tested
- Primary Fascial Closure, wound vac dressing application
- Keywords
- damage control, resuscitation, laparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Fascial ClosureProcedure or surgery
Abdominal wall closure following damage control laparotomy.
wound vac dressing applicationDevice
Also called AbThera woulnd vac (KCI)
temporary abdominal wall closure with this device after damage control laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid resuscitation | Active comparator | Patients to receive normal saline resuscitation at a rate of 30cc/hr. Receives: Procedure: Primary Fascial Closure; Device: wound vac dressing application |
| Hypertonic saline resuscitation | Active comparator | Patients to receive 3% hypertonic saline resuscitation at a rate of 30cc/hr. Receives: Procedure: Primary Fascial Closure; Device: wound vac dressing application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieve primary fascial closure
Is there a higher rate of PFC among patients who undergo DCL and temporary abdominal closure when using HTS versus standard crystalloid resuscitation?
Measured: 2 weeks
Secondary outcomes (7)
number of ICU free days
Does successful and faster PFC reduce ICU days?
Measured: 30 days
number of enterocutaneous fistula
Does faster and more successful PFC result in reduction enterocutaneous fistula (ECF)?
Measured: 90 days
number of intra abdominal abscess
Does faster and more successful PFC result in reduction of intra-abdominal abscess (IAA)?
Measured: 90 days
number of abdominal wall hernias
Does faster and more successful PFC result in reduction in abdominal wall hernia?
Measured: 90 days
number of anastomotic failure
Does faster and more successful PFC result in a reduction in anastomotic failure?
Measured: 90 days
number of ventilator free days
Does successful and faster PFC reduce ventilator days?
Measured: 30 days
number of hospital free days
Does successful and faster PFC reduce hospital days?
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Abdomen After Damage Control LaparotomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Antonio Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Valerie Sams, San Antonio Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297659
- Sponsor's protocol ID
- 397284-1
- Status last verified
- Dec 2015
- First submitted
- 1 Aug 2014
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harvin JA, Mims MM, Duchesne JC, Cox CS Jr, Wade CE, Holcomb JB, Cotton BA. Chasing 100%: the use of hypertonic saline to improve early, primary fascial closure after damage control laparotomy. J Trauma Acute Care Surg. 2013 Feb;74(2):426-30; discussion 431-2. doi: 10.1097/TA.0b013e31827e2a96.
PubMed 23354234
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure
- ClinicalTrials.gov ID
- NCT02297659
- Acronym / sponsor ID
- 397284-1
- Keywords
- damage control, resuscitation, laparotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- San Antonio Military Medical CenterUS federal agency
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- 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.
Damage control laparotomy (DCL) has proven to be a successful means to improve survival in severely injured patients.1-5 However, the consequences of not being able to close the fascia after the initial operation due to significant resuscitation leading to bowel and retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC) contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias, enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or standard crystalloid solutions after DCL and compare the time to PFC, rate of successful closure, and rate of complications associated with an open abdomen. The current failure rate of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using hypertonic saline.
Detailed description
The use of HTS after DCL may decrease the rate of failure to achieve PFC and reduce the number of complications associated with an open abdomen.
Research Questions:
- Primary Objective: Is there a higher rate of PFC among patients who undergo DCL and temporary abdominal closure when using HTS versus standard crystalloid resuscitation?
- Secondary Objectives: Does successful and faster PFC reduce ICU, ventilator and hospital days?
- Does faster and more successful PFC result in lower morbidity to include enterocutaneous fistula (ECF), intra-abdominal abscess (IAA), abdominal wall hernia, and anastomotic failure?
DCL is a common procedure wounded warriors undergo due to blast and other blunt and penetrating mechanisms of injury. This results in a significant population of warriors at risk for all of the complications and comorbidities that accompany an open abdomen. Thus, finding ways to not only achieve PFC but also to decrease the time to PFC will reduce these unwanted events.
The protocol design is a multi-institutional, prospective, double blind, randomized controlled trial of patients who undergo DCL for abdominal trauma requiring temporary abdominal closure and return to operating room for definitive treatment. All participating facilities are Level I Trauma Centers. Currently, the standard of care for damage control resuscitation involves all intravenous fluid solutions utilized in this study; normal saline, Ringer's lactate, Plasmalyte, and 3% saline (HTS). However, the type of fluid is selected based on surgeon preference alone. Investigators will randomize patients to normal saline at a resuscitation rate of 30 cc/hr or to 3% saline (HTS) at a resuscitation rate of 30cc/hr which will be initiated upon arrival to the ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid resuscitation | Active comparator | Procedure: Primary Fascial Closure, Device: wound vac dressing applicationPatients to receive normal saline resuscitation at a rate of 30cc/hr. |
| Hypertonic saline resuscitation | Active comparator | Procedure: Primary Fascial Closure, Device: wound vac dressing applicationPatients to receive 3% hypertonic saline resuscitation at a rate of 30cc/hr. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All admissions of trauma patients who sustain trauma necessitating damage control laparotomy.
- Male and female patients 18 years or older.
Key exclusion criteria (3 listed)
- Children (<18 years old), prisoners, or pregnant patients.
- Patients who have more than 1/3 loss of abdominal wall due to trauma.
- Patients with baseline serum sodium of <120 mEq/L or >155 mEq/L.
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 |
|---|---|---|
| Primary Fascial ClosureAbdominal wall closure following damage control laparotomy. | Procedure or surgery | Crystalloid resuscitation, Hypertonic saline resuscitation |
| wound vac dressing applicationAlso: AbThera woulnd vac (KCI)temporary abdominal wall closure with this device after damage control laparotomy | Device | Crystalloid resuscitation, Hypertonic saline resuscitation |
Primary outcome
Number of participants who achieve primary fascial closure
Time frame: 2 weeks
Is there a higher rate of PFC among patients who undergo DCL and temporary abdominal closure when using HTS versus standard crystalloid resuscitation?
7 secondary outcomes
number of ICU free days
Time frame: 30 days
number of enterocutaneous fistula
Time frame: 90 days
number of intra abdominal abscess
Time frame: 90 days
number of abdominal wall hernias
Time frame: 90 days
number of anastomotic failure
Time frame: 90 days
number of ventilator free days
Time frame: 30 days
number of hospital free days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Background: PubMed 23354234Harvin JA, Mims MM, Duchesne JC, Cox CS Jr, Wade CE, Holcomb JB, Cotton BA. Chasing 100%: the use of hypertonic saline to improve early, primary fascial closure after damage control laparotomy. J Trauma Acute Care Surg. 2013 Feb;74(2):426-30; discussion 431-2. doi: 10.1097/TA.0b013e31827e2a96.
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.
San Antonio Military Medical Center
San Antonio, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Fascial Closure and wound vac dressing application in people with Open Abdomen After Damage Control Laparotomy, run by San Antonio Military Medical Center 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Dec 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who achieve primary fascial closure (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02297659, which also lists 1 linked publication.
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 15 Dec 2015.