Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

NCT02461433 | Terminated Results FDA Device

• 1 other identifier: IRB00030337
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection, Surgical; Obesity; Postoperative Complications

Keywords

Obesity; Obese; surgical site infection; closed incisions; negative pressure therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Other Wound Complications (Aggregate)

  Up to 14 days postop

• Skin Bacterial Count as Assessed by Microbacterial Count

  Up to 7 days postop

• Physical Function as Assessed by Short Form Survey (SF) 36

  Up to 14 days postop

• Readmissions

  Up to 30 days postop

• Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36

  Up to 14 days postop

Study Arms (2)

Prevena

EXPERIMENTAL

After surgery this group will receive the Prevena device (negative pressure wound therapy).

Device: Prevena

Standard dressing

ACTIVE COMPARATOR

After surgery this group will receive standard of care dressings on their surgical wound.

Device: Standard Dressing

Interventions

Prevena DEVICE

Prevena Incision Management system

Prevena

Standard Dressing DEVICE

This involves standard of care dressing including but not limited to gauze.

Standard dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (1)

Johns Hopkins Medical Institutes

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Obesity; Postoperative Complications

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Results Point of Contact

• Title: Mahmoud Malas
• Organization: Johns Hopkins University

bmalas1@jhmi.edu

410-550-4546

Study Officials

• Kimberley Steele, MD, PHD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 26, 2019
• Results First Posted: February 12, 2018

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)