Trial Outcomes & Findings for Standard Versus PICO Dressings in Lower-Extremity Bypass Patients (NCT NCT02492854)
NCT ID: NCT02492854
Last Updated: 2021-11-04
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
30 days
Results posted on
2021-11-04
Participant Flow
Participant milestones
| Measure |
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.
|
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 surgical-site infections (SSIs) post-lower extremity (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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
Baseline characteristics by cohort
| Measure |
Standard Sterile Gauze Dressings
n=5 Participants
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.
|
PICO Negative Pressure Dressings
n=3 Participants
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.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe 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.
Outcome measures
| Measure |
Standard Sterile Gauze Dressings
n=5 Participants
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.
|
PICO Negative Pressure Dressings
n=3 Participants
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.
|
|---|---|---|
|
Composite Score for Post-Operative Recovery
|
0.80 scores on a scale
Standard Deviation 0.45
|
0.33 scores on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
Standard Sterile Gauze Dressings
n=2 Participants
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.
|
PICO Negative Pressure Dressings
n=3 Participants
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.
|
|---|---|---|
|
Function and Quality of Life Based on the Vascular Quality of Life Survey
|
121.50 scores on a scale
Standard Deviation 7.78
|
144.67 scores on a scale
Standard Deviation 6.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: Since the study was terminated, this outcome measure was not assessed for any of the participants.
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.
Outcome measures
Outcome data not reported
Adverse Events
Standard Sterile Gauze Dressings
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
PICO Negative Pressure Dressings
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Sterile Gauze Dressings
n=5 participants at risk
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.
|
PICO Negative Pressure Dressings
n=3 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
|
Infections and infestations
Surgical Site Infection
|
0.00%
0/5 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.00%
0/5 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Abcess
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
|
Infections and infestations
Infected bypass graft
|
0.00%
0/5 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute chest pain
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
Other adverse events
| Measure |
Standard Sterile Gauze Dressings
n=5 participants at risk
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.
|
PICO Negative Pressure Dressings
n=3 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulites
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
|
Vascular disorders
Peripheral arterial disease
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/5 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
|
Infections and infestations
Fever
|
0.00%
0/5 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
|
Infections and infestations
Serosanguisous discharge
|
0.00%
0/5 • 12 months
|
33.3%
1/3 • Number of events 1 • 12 months
|
|
Infections and infestations
Redness and swellig
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place