Spinal Deformity
Conditions
Keywords
Spinal Deformity, Complex Spinal Surgery, Negative Pressure Wound Therapy, Post-Operative Infection
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>/= 18 years of age * \>/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
Exclusion criteria
* \< 18 years of age * \< 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion * Spinal infection at time of surgery * History of immunosuppression or chronic systemic infection * Pregnancy * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-operative Infection (NPWT) | 3 months | The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| NPWT Arm Therapy This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Negative pressure wound therapy (NPWT) | 11 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | No Negative Pressure Wound Therapy Device | NPWT Arm Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 9 Participants | 13 Participants |
| Region of Enrollment United States | 8 participants | 11 participants | 19 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 11 |
| serious Total, serious adverse events | 1 / 8 | 0 / 11 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Negative Pressure Wound Therapy Device | Number of Participants With Post-operative Infection (NPWT) | 1 participants |
| NPWT Arm Therapy | Number of Participants With Post-operative Infection (NPWT) | 2 participants |