Open AbdomenOASITNCT01594385
Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
A study testing Seprafilm in people with Open Abdomen and Abdominal Adhesions, run by Stan Stawicki at 5 sites in United States.
Trial summary
The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Open Abdomen, Abdominal Adhesions, Trauma
- What is being tested?
- Seprafilm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma patients undergoing DC/OA management for traumatic injury
- Age 18+
- Life expectancy longer than 48 hours
Who cannot join
- Prisoners
- Pregnant patients
- Younger than 18 years of age
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
Cooper University Hospital
Camden, New Jersey, 08103
Carolinas Medical Center
Charlotte, North Carolina, 32861
The Ohio State University Medical Center
Columbus, Ohio, 43210
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)
The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:
- the number and intensity of adhesions,
- whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,
- rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and
- whether there is any difference between treatment groups regarding patient functional recovery.
Read the detailed description
Data to be analyzed includes:
Age, gender, traumatic injuries, trauma alert level, procedure information, length of hospital stay, length of ICU stay, interval between admission and initial operation, interval between operations, whether operation took place during the day or night, duration of operation in minutes, number of surgeons present during the operation, description of the initial operation, justification for using damage control approach, complications noted, injuries missed or delayed in diagnosis, Acute Physiology and Chronic Health Evaluation II (APACHE II) calculations at various time points, Simplified Acute Physiology Score (SAPS II) calculations at various time points, Glasgow Coma Score (GCS) calculations at various time points, changes in GCS at over time, Injury Severity Score (ISS) at various time points, Abbreviated Injury Scale (AIS) at various time points, Penetrating Abdominal Trauma Index score (if applicable) at various time points, complete blood count (CBC) results at various time points, blood chemistry results at various time points, blood gas results at various time points, subject randomization information, number of operations, adhesion scores (Zuhlke and Yaacobi) for each operative procedure, contamination score for each operative procedure, diagnosis and description of sub-procedures for each operative procedure, wound characteristics from the start and end of all operative procedures (e.g. length and width of the fascia and skin), type of abdominal coverage or closure, discharge destination (e.g. home, short term rehabilitation facility, etc.), Functional Outcome Measure score, Glasgow Outcome Score (GOS) at various time points, number and interval of post discharge follow-up visits, wound characteristics since discharge at several time points and complications/complaints noted since discharge at several time points.
- Conditions
- Open Abdomen, Abdominal Adhesions, Trauma, Wounds and Injury
- Being tested
- Seprafilm
- Keywords
- Open Abdomen, Damage Control, Trauma, Wound healing, Gun shot wounds, Stab wounds, Automobile accidents, Wounds and Injury
- Medical subject headings
- Wounds and Injuries, Wounds, Stab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeprafilmBiological
Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:
- Two Seprafilm pieces between the liver and the anterior abdominal wall
- Four pieces over the exposed bowel surfaces anteriorly
- Two slightly staggered pieces of Seprafilm in each colic gutter
- Two pieces in the pelvic area.
- If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair.
| Study group | Role | What they receive |
|---|---|---|
| Seprafilm | Other | The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio. Receives: Biological: Seprafilm |
| No Seprafilm | No intervention | This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion Characteristics
Zuhlke adhesion score (1 - minimum to 4 - maximum)
- = filmy adhesions, easy to separate by blunt dissection
- = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization
- = strong adhesions; lysis possible by sharp dissection only; clear vascularization
- = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable
Measured: Up to 1 year
Secondary outcomes (1)
Wound Healing Characteristics
There will not be a fixed duration of outpatient follow-up (fixed follow-up in trauma patients is not practical due to the unpredictable nature of trauma population), an average (mean) follow-up will be determined for the entire cohort of patients for the purposes of the study, up to a maximum of 1 year (if available) following hospital discharge.
Measured: Participants will be followed until their open abdomen is closed. Depending on the nature and severity of the wound, this period may last as long as 1 year after the patient has been discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2010
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stan Stawicki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania
- Investigators
- Stanislaw P Stawicki, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594385
- Sponsor's protocol ID
- 2009H0311
- Acronym
- OASIT
- Status last verified
- Oct 2017
- First submitted
- 5 Jan 2012
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Currently, the only available data is de-identified dataset without any linkages to the original data. Data storage currently past record-keeping requirements. Study was permanently closed in June 2014.
Publications
Stawicki SP, Green JM, Martin ND, Green RH, Cipolla J, Seamon MJ, Eiferman DS, Evans DC, Hazelton JP, Cook CH, Steinberg SM; OPUS 12 Foundation, Inc, Multi-Center Trials Group & OASIT Investigators. Results of a prospective, randomized, controlled study of the use of carboxymethylcellulose sodium hyaluronate adhesion barrier in trauma open abdomens. Surgery. 2014 Aug;156(2):419-30. doi: 10.1016/j.surg.2014.03.007. Epub 2014 Mar 15.
PubMed 24962185
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)
- ClinicalTrials.gov ID
- NCT01594385
- Acronym / sponsor ID
- OASIT / 2009H0311
- Conditions
- Open Abdomen, Abdominal Adhesions, Trauma, Wounds and Injury
- Keywords
- Open Abdomen, Damage Control, Trauma, Wound healing, Gun shot wounds, Stab wounds, Automobile accidents, Wounds and Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stan StawickiUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:
- the number and intensity of adhesions,
- whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,
- rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and
- whether there is any difference between treatment groups regarding patient functional recovery.
Detailed description
Data to be analyzed includes:
Age, gender, traumatic injuries, trauma alert level, procedure information, length of hospital stay, length of ICU stay, interval between admission and initial operation, interval between operations, whether operation took place during the day or night, duration of operation in minutes, number of surgeons present during the operation, description of the initial operation, justification for using damage control approach, complications noted, injuries missed or delayed in diagnosis, Acute Physiology and Chronic Health Evaluation II (APACHE II) calculations at various time points, Simplified Acute Physiology Score (SAPS II) calculations at various time points, Glasgow Coma Score (GCS) calculations at various time points, changes in GCS at over time, Injury Severity Score (ISS) at various time points, Abbreviated Injury Scale (AIS) at various time points, Penetrating Abdominal Trauma Index score (if applicable) at various time points, complete blood count (CBC) results at various time points, blood chemistry results at various time points, blood gas results at various time points, subject randomization information, number of operations, adhesion scores (Zuhlke and Yaacobi) for each operative procedure, contamination score for each operative procedure, diagnosis and description of sub-procedures for each operative procedure, wound characteristics from the start and end of all operative procedures (e.g. length and width of the fascia and skin), type of abdominal coverage or closure, discharge destination (e.g. home, short term rehabilitation facility, etc.), Functional Outcome Measure score, Glasgow Outcome Score (GOS) at various time points, number and interval of post discharge follow-up visits, wound characteristics since discharge at several time points and complications/complaints noted since discharge at several time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seprafilm | Other | Biological: SeprafilmThe treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio. |
| No Seprafilm | No intervention | –This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Trauma patients undergoing DC/OA management for traumatic injury
- Age 18+
- Life expectancy longer than 48 hours
Key exclusion criteria (3 listed)
- Prisoners
- Pregnant patients
- Younger than 18 years of age
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 |
|---|---|---|
| SeprafilmTwo sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas: * Two Seprafilm pieces between the liver and the anterior abdominal wall * Four pieces over the exposed bowel surfaces anteriorly * Two slightly staggered pieces of Seprafilm in each colic gutter * Two pieces in the pelvic area. * If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair. | Biological | Seprafilm |
Primary outcome
Adhesion Characteristics
Time frame: Up to 1 year
Zuhlke adhesion score (1 - minimum to 4 - maximum) 1. = filmy adhesions, easy to separate by blunt dissection 2. = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization 3. = strong adhesions; lysis possible by sharp dissection only; clear vascularization 4. = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable
1 secondary outcome
Wound Healing Characteristics
Time frame: Participants will be followed until their open abdomen is closed. Depending on the nature and severity of the wound, this period may last as long as 1 year after the patient has been discharged.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24962185Stawicki SP, Green JM, Martin ND, Green RH, Cipolla J, Seamon MJ, Eiferman DS, Evans DC, Hazelton JP, Cook CH, Steinberg SM; OPUS 12 Foundation, Inc, Multi-Center Trials Group & OASIT Investigators. Results of a prospective, randomized, controlled study of the use of carboxymethylcellulose sodium hyaluronate adhesion barrier in trauma open abdomens. Surgery. 2014 Aug;156(2):419-30. doi: 10.1016/j.surg.2014.03.007. Epub 2014 Mar 15.
- Individual participant dataSharing planned: No. Currently, the only available data is de-identified dataset without any linkages to the original data. Data storage currently past record-keeping requirements. Study was permanently closed in June 2014.
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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.
Stanislaw P Stawicki, MD principal investigator
Ohio State University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seprafilm in people with Open Abdomen and Abdominal Adhesions, run by Stan Stawicki at 5 sites 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 3 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: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adhesion Characteristics (time frame: Up to 1 year). 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 NCT01594385, 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 20 Nov 2017.