An interventional study of Prevena and Standard Dressing in Wound Infection, Surgical, Obesity and Postoperative Complications, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's enrollment of 2 is below the median of 200 across 526 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Device: Prevena
After surgery this group will receive standard of care dressings on their surgical wound.
Device: Standard Dressing
Prevena Incision Management system
This involves standard of care dressing including but not limited to gauze.
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
Time frame: Up to 7 days postop
Other Wound Complications (Aggregate)
Dehiscence, seroma and hematoma. Reported as number of aggregate events.
Time frame: 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
Time frame: 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
Time frame: Up to 14 days postop
Readmissions
Readmission events for the patients.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 14 days postop
| Milestone | Prevena | Standard Dressing |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery
| Surgical Site infections | Prevena | Standard Dressing |
|---|---|---|
| Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines | 0 | 0 |
Dehiscence, seroma and hematoma. Reported as number of aggregate events.
| aggregate wound complication events | Prevena | Standard Dressing |
|---|---|---|
| Other Wound Complications (Aggregate) | 0 | 0 |
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
No measurements were reported for this outcome.
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
| units on a scale | Prevena | Standard Dressing |
|---|---|---|
| Physical Function as Assessed by Short Form Survey (SF) 36 | 100 (100 to 100) | 85 (85 to 85) |
Readmission events for the patients.
| readmission events | Prevena | Standard Dressing |
|---|---|---|
| Readmissions | 0 | 0 |
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
| units on a scale | Prevena | Standard Dressing |
|---|---|---|
| Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36 | 100 (100 to 100) | 100 (100 to 100) |
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
| units on a scale | Prevena | Standard Dressing |
|---|---|---|
| Social Functioning as Assessed by Short Form Survey (SF) 36 | 100 (100 to 100) | 100 (100 to 100) |
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
| units on a scale | Prevena | Standard Dressing |
|---|---|---|
| Energy / Fatigue as Assessed by Short Form Survey (SF) 36 | 50 (50 to 50) | 75 (75 to 75) |
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
| units on a scale | Prevena | Standard Dressing |
|---|---|---|
| Emotional Well Being as Assessed by Short Form Survey (SF) 36 | 60 (60 to 60) | 60 (60 to 60) |
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
| units on a scale | Prevena | Standard Dressing |
|---|---|---|
| Pain as Assessed by Short Form Survey (SF) 36 | 100 (100 to 100) | 100 (100 to 100) |
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
| units on a scale | Prevena | Standard Dressing |
|---|---|---|
| General Health as Assessed by Short Form Survey (SF) 36 | 100 (100 to 100) | 65 (65 to 65) |
Collected over From consent to end of study (30 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prevena | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Standard Dressing | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(years) | Prevena | Standard Dressing | Total |
|---|---|---|---|
| Mean | 34 (34 to 34) | 45 (45 to 45) | 39.5 (34 to 45) |
| Sex: Female, Male(Participants) | Prevena | Standard Dressing | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | Prevena | Standard Dressing | Total |
|---|---|---|---|
| African American | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Prevena | Standard Dressing | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Prevena | Standard Dressing | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
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