N/A
N=30
Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
Open Abdomen · Abdominal Adhesions · Trauma · Wounds and Injury
Bottom Line
View on ClinicalTrials.gov: NCT01594385 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
May 2017
Primary outcome: Primary: Adhesion Characteristics — 1.06; 1.08; 1.13; 1.08 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Seprafilm (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stan Stawicki
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adhesion Characteristics |
1.06; 1.08; 1.13; 1.08; 1.54; 1.19 | — |
| SECONDARY Wound Healing Characteristics |
419; 393; 282; 322; 223; 218 | — |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01594385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.