Cardiovascular Diseases, Of Bypass Graft of the Extremities, Peripheral Arterial Disease, Vascular Diseases
Conditions
Keywords
Lower Extremity Bypass, Surgical Site Infection, Wound Dressing, Negative Pressure Wound Dressing
Brief summary
The objective of this study is to compare the effectiveness of standard moist dressings and PICO single-use negative pressure dressings in post-operative lower extremity bypass patients. This study will compare the dressings' ability to decrease swelling, decrease post-operative infection, and improve mobility and quality of life measures. Subjects will be asked to participate in this study because they will undergo a lower extremity bypass using the ipsilateral great saphenous vein. Subjects will then be randomized to two post-operative treatment groups. One group will receive standard sterile gauze and the other will receive PICO single-use negative pressure dressings. Both groups will be assessed for study measures in follow-up visits as clinically indicated up to 1 year with the 30 day timepoint as the primary outcome for study measures.
Detailed description
Post-operative infection after lower extremity bypass operations (LEB) can lead to devastating consequences. A systematic review of lower-extremity (LE) re-vascularization cases using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) found that 11.1% of patients were diagnosed with surgical site infections (SSI). Another main issue in LEB is swelling, which occurs in about 70% of these patients and leads to increased pressure along the leading edges of often-long wounds. A wide variety of methods to decrease these post-operative consequences are currently part of standard practice. These techniques include covering incision sites with sterile gauze dressing, elevating the leg, and wrapping with pressure dressings. Patients are then instructed to change dressings themselves at home. However, SSI rates demonstrate that these are only partially effective measures, and there remains room to improve post-operative management of infection and swelling. Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds (see device description). PICO single-use negative pressure dressings have been examined in previous studies. However, these were either case series, for chronic wounds, or for non-vascular procedures. The effectiveness of PICO versus standard dressings in LEB has yet to be determined in a prospective, comparative study. Results will indicate whether PICO should be included standard post-operative care of lower-extremity bypass patients. This study is designed to compare PICO and standard care, and determine which offers the best outcomes of decreased days to ambulation and post-operative wound complications.
Interventions
DEVICEPICO Single-Use Negative Pressure Dressings
Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds. This is a therapy with potential to decrease rates of SSIs post-LE bypass. Unlike standard gauze dressings, negative pressure wound therapy provides a sealed, moist environment and shuttles fluid away from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 mmHg) and exudate is suctioned and collected in a control unit. The investigators would like to investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, both of which allow for ease of use. PICO has been FDA-approved.
OTHERSterile Gauze Dressings
Current standard-of-care dressings used to cover surgical wounds post-operatively.
Sponsors
Smith & Nephew, Inc.
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 35 years * Patient to undergo lower extremity bypass using ipsilateral great saphenous vein harvest * Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Exclusion criteria
* Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days * Inability or refusal to provide informed consent * Pregnancy or lactation * Current immune-suppressive medication, chemotherapy, or radiation therapy * Any infrainguinal revascularization procedure on index leg within 12 weeks prior to treatment * Life expectancy of less than 2 years * Prior leg bypass on the ipsilateral limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Score for Post-Operative Recovery | 30 days | The primary endpoint is lower-extremity bypass post-operative recovery that is free of major complications at 30 days post operation. This will be measured by a composite score based on three outcomes- leg swelling, ambulation, and infection (defined as antibiotics being prescribed). Each will be assigned a 0 if not present or a 1 if present and then summed for the composite score. The range can be from 0 to 3 with higher scores associated with more complications associated with surgical site infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function and Quality of Life Based on the Vascular Quality of Life Survey | 1 year | The Vascular Quality of Life (VascuQol) survey is a 25 item instrument that is used to assess function and quality of life. Every item has a 7-point response scale ranging from 1 (worst) to 7 (best). The range of scores is 25 to 175. Higher scores are associated with higher function and quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resource Utilization in Dollars [Composite Measure] | 1 year | The resource utilization will be calculated from costs associated with the length of stay and discharge to rehabilitation centers which will be abstracted form the medical records. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Sterile Gauze Dressings In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.
Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively. | 5 |
| PICO Negative Pressure Dressings In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.
PICO Single-Use Negative Pressure Dressings: Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds. This is a therapy with potential to decrease rates of SSIs post-LE bypass. Unlike standard gauze dressings, negative pressure wound therapy provides a sealed, moist environment and shuttles fluid away from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 mmHg) and exudate is suctioned and collected in a control unit. The investigators would like to investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, both of which allow for ease of use. PICO has been FDA-approved. | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | Standard Sterile Gauze Dressings | Total | PICO Negative Pressure Dressings |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 8.3 | 60.4 years STANDARD_DEVIATION 9 | 60.3 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 1 Participants |
| Region of Enrollment United States | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 3 / 5 | 1 / 3 |
| serious Total, serious adverse events | 3 / 5 | 1 / 3 |
Outcome results
Primary
Composite Score for Post-Operative Recovery
The primary endpoint is lower-extremity bypass post-operative recovery that is free of major complications at 30 days post operation. This will be measured by a composite score based on three outcomes- leg swelling, ambulation, and infection (defined as antibiotics being prescribed). Each will be assigned a 0 if not present or a 1 if present and then summed for the composite score. The range can be from 0 to 3 with higher scores associated with more complications associated with surgical site infection.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Sterile Gauze Dressings | Composite Score for Post-Operative Recovery | 0.80 scores on a scale | Standard Deviation 0.45 |
| PICO Negative Pressure Dressings | Composite Score for Post-Operative Recovery | 0.33 scores on a scale | Standard Deviation 0.58 |
Secondary
Function and Quality of Life Based on the Vascular Quality of Life Survey
The Vascular Quality of Life (VascuQol) survey is a 25 item instrument that is used to assess function and quality of life. Every item has a 7-point response scale ranging from 1 (worst) to 7 (best). The range of scores is 25 to 175. Higher scores are associated with higher function and quality of life.
Time frame: 1 year
Population: For the Standard Sterile Gauze Dressing arm, data were not collected for 3 of the 5 participants as the study was terminated before 1 year of follow-up for those participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Sterile Gauze Dressings | Function and Quality of Life Based on the Vascular Quality of Life Survey | 121.50 scores on a scale | Standard Deviation 7.78 |
| PICO Negative Pressure Dressings | Function and Quality of Life Based on the Vascular Quality of Life Survey | 144.67 scores on a scale | Standard Deviation 6.66 |
Other Pre-specified
Resource Utilization in Dollars [Composite Measure]
The resource utilization will be calculated from costs associated with the length of stay and discharge to rehabilitation centers which will be abstracted form the medical records.
Time frame: 1 year
Population: Since the study was terminated, this outcome measure was not assessed for any of the participants.