Trauma Clinical Trial
— OASITOfficial title:
Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)
Verified date | October 2017 |
Source | St. Luke's Hospital and Health Network, Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Trauma patients undergoing DC/OA management for traumatic injury - Age 18+ - Life expectancy longer than 48 hours Exclusion Criteria: - Prisoners - Pregnant patients - Younger than 18 years of age |
Country | Name | City | State |
---|---|---|---|
United States | St. Luke's Hospital | Bethlehem | Pennsylvania |
United States | Cooper University Hospital | Camden | New Jersey |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | The Ohio State University Medical Center | Columbus | Ohio |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Stan Stawicki |
United States,
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 o — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Mortality | Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up) | 28 days & end of follow-up | |
Other | Enterocutaneous and Other Fistula | Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval | Up to 1 year post-injury | |
Other | Ventral Hernia | Determination of ventral hernia presence during follow-up visits | Up to 1 year follow-up | |
Other | Infection / Abscess / Sepsis | Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods | Up to 1 year | |
Other | Bowel Obstruction | Determination of bowel obstruction during the entire available study follow-up period | Up to 1 year follow-up | |
Other | Patient Functional Outcomes | Assessment of Glasgow Outcome Scale (GOS) and the Functional Outcome Measures (FOM) during the available follow-up period. FOM Source: [1] Ohio Dept of Public Safety. Ohio Trauma Registry Data Dictionary. Columbus: 2004. FOM Scale range: 1 (worst) to 4 (best); GOS Scale: 1 (worst) to 5 (best) FOM Feeding Subscale Fully dependent Partially dependent Independent w/device Fully independent FOM Locomotion Subscale Fully dependent Partially dependent Independent w/device Fully independent FOM Expression/Communication Subscale Fully dependent Partially dependent Independent w/device Fully independent Glasgow Outcome Scale: Death Persistent vegetative state: Minimal responsiveness Severe disability: Conscious but disabled; dependent on others for daily support Moderate disability: Disabled but independent; can work in sheltered setting Good recovery: Resumption of normal life despite minor deficits |
Up to 1 year follow-up | |
Other | Would Complication | Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint | Up to 1 year follow-up period | |
Primary | 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 |
Up to 1 year | |
Secondary | 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. | 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. |
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