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Sponsor pulled funding
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| Name | Class |
|---|---|
| Kinetic Concepts, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevena | Experimental | After surgery this group will receive the Prevena device (negative pressure wound therapy). |
|
| Standard dressing | Active Comparator | After surgery this group will receive standard of care dressings on their surgical wound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena | Device | Prevena Incision Management system |
| |
| Standard Dressing |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other Wound Complications (Aggregate) | Dehiscence, seroma and hematoma. Reported as number of aggregate events. | Up to 14 days postop |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberley Steele, MD, PHD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutes | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevena | After surgery this group will receive the Prevena device (negative pressure wound therapy). Prevena: Prevena Incision Management system |
| FG001 | Standard Dressing | After surgery this group will receive standard of care dressings on their surgical wound. Standard Dressing: This involves standard of care dressing including but not limited to gauze. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevena | After surgery this group will receive the Prevena device (negative pressure wound therapy). Prevena: Prevena Incision Management system |
| BG001 | Standard Dressing | After surgery this group will receive standard of care dressings on their surgical wound. Standard Dressing: This involves standard of care dressing including but not limited to gauze. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | Surgical Site infections | Up to 7 days postop |
|
From consent to end of study (30 days)
Used a checklist to inquire about would feeling, and systemic effects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevena | After surgery this group will receive the Prevena device (negative pressure wound therapy). Prevena: Prevena Incision Management system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Malas | Johns Hopkins University | 410-550-4546 | bmalas1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2016 | Feb 2, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D009765 | Obesity |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
This involves standard of care dressing including but not limited to gauze. |
|
| Up to 7 days postop |
| 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 |
| Readmissions | Readmission events for the patients. | Up to 30 days postop |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Region of Enrollment | Location of where the participant was enrolled. | Count of Participants | Participants |
|
|
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| Secondary | Other Wound Complications (Aggregate) | Dehiscence, seroma and hematoma. Reported as number of aggregate events. | Posted | Number | aggregate wound complication 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 | The samples were not sent to the lab | Posted | 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 | Posted | Mean | Full Range | units on a scale | Up to 14 days postop |
|
|
|
| Secondary | Readmissions | Readmission events for the patients. | Posted | Number | readmission events | 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 | Posted | Mean | Full Range | units on a scale | 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 | Posted | Mean | Full Range | units on a scale | 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 | Posted | Mean | Full Range | units on a scale | 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 | Posted | Mean | Full Range | units on a scale | 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 | Posted | Mean | Full Range | units on a scale | 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 | Posted | Mean | Full Range | units on a scale | Up to 14 days postop |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Standard Dressing | After surgery this group will receive standard of care dressings on their surgical wound. Standard Dressing: This involves standard of care dressing including but not limited to gauze. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |