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The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.
This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Negative Pressure Wound Therapy Device | No Intervention | This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine. | |
| NPWT Arm Therapy | Experimental | This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative pressure wound therapy (NPWT) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-operative Infection (NPWT) | The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos A Bagley, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Negative Pressure Wound Therapy Device | This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine. |
| FG001 | NPWT Arm Therapy | This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Negative pressure wound therapy (NPWT) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Negative Pressure Wound Therapy Device | This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine. |
| BG001 | NPWT Arm Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Post-operative Infection (NPWT) | The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period. | Posted | Number | participants | 3 months |
|
pre-op - 3 months
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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 | No Negative Pressure Wound Therapy Device | This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Nervous system disorders | Non-systematic Assessment | Patient developed a neurodegenerative disorder while an inpatient, and subsequently passed away. She did not receive the negative pressure wound therapy device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos A. Bagley | Duke | 919-943-1564 | carlos.bagley@gmail.com |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Negative pressure wound therapy (NPWT)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 8 |
| 0 |
| 8 |
| EG001 | NPWT Arm Therapy | This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Negative pressure wound therapy (NPWT) | 0 | 11 | 0 | 11 |
|
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