Obesity Clinical Trial
— SAVIOROfficial title:
The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
NCT number | NCT02461433 |
Other study ID # | IRB00030337 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | March 2017 |
Verified date | February 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.
Status | Terminated |
Enrollment | 2 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site. - Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes. - Patient with BMI= 30 at the time of surgery - Patient agrees to return for all required clinical follow up for the study. Exclusion Criteria: - Known allergic reaction to acrylic adhesives or silver. - Known history of intolerance to any component of Prevena Incision Management System TM. - Very fragile skin around incision site. - Bleeding disorder or refuses blood transfusion. - Malignancy or other condition limiting life expectancy to <5 years. - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Medical Institutes | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Kinetic Concepts, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines | The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery | Up to 7 days postop | |
Secondary | Other Wound Complications (Aggregate) | Dehiscence, seroma and hematoma. Reported as number of aggregate events. | Up to 14 days postop | |
Secondary | Skin Bacterial Count as Assessed by Microbacterial Count | Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count | Up to 7 days postop | |
Secondary | Physical Function as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | |
Secondary | Readmissions | Readmission events for the patients. | Up to 30 days postop | |
Secondary | Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | |
Secondary | Social Functioning as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | |
Secondary | Energy / Fatigue as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | |
Secondary | Emotional Well Being as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | |
Secondary | Pain as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop | |
Secondary | General Health as Assessed by Short Form Survey (SF) 36 | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Up to 14 days postop |
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