Clinical trial NCT02461433: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
Official title: The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Infection, Surgical
Obesity
Postoperative Complications
Keywords: Obesity
Obese
surgical site infection
closed incisions
negative pressure therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2015-06-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date.

The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines
timeFrame: Up to 7 days postop
Secondary outcomes:
measure: Other Wound Complications (Aggregate)
timeFrame: Up to 14 days postop
measure: Skin Bacterial Count as Assessed by Microbacterial Count
timeFrame: Up to 7 days postop
measure: Physical Function as Assessed by Short Form Survey (SF) 36
timeFrame: Up to 14 days postop
measure: Readmissions
timeFrame: Up to 30 days postop
measure: Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36
timeFrame: Up to 14 days postop
measure: Social Functioning as Assessed by Short Form Survey (SF) 36
timeFrame: Up to 14 days postop
measure: Energy / Fatigue as Assessed by Short Form Survey (SF) 36
timeFrame: Up to 14 days postop
measure: Emotional Well Being as Assessed by Short Form Survey (SF) 36
timeFrame: Up to 14 days postop
measure: Pain as Assessed by Short Form Survey (SF) 36
timeFrame: Up to 14 days postop
measure: General Health as Assessed by Short Form Survey (SF) 36
timeFrame: Up to 14 days postop
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutes
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kimberley Steele, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: