Of Bypass Graft of the ExtremitiesPICO-LEBNCT02492854
Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
A study testing PICO Single-Use Negative Pressure Dressings and Sterile Gauze Dressings in people with Of Bypass Graft of the Extremities and Peripheral Arterial Disease, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Of Bypass Graft of the Extremities, Peripheral Arterial Disease, Vascular Diseases
- What is being tested?
- PICO Single-Use Negative Pressure Dressings and Sterile Gauze Dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2015to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Of Bypass Graft of the Extremities, Peripheral Arterial Disease, Vascular Diseases, Cardiovascular Diseases
- Being tested
- PICO Single-Use Negative Pressure Dressings, Sterile Gauze Dressings
- Keywords
- Lower Extremity Bypass, Surgical Site Infection, Wound Dressing, Negative Pressure Wound Dressing
- Medical subject headings
- Peripheral Arterial Disease, Vascular Diseases, Cardiovascular Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO Single-Use Negative Pressure DressingsDevice
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.
Sterile Gauze DressingsOther
Current standard-of-care dressings used to cover surgical wounds post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Standard Sterile Gauze Dressings | Active comparator | In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. Receives: Other: Sterile Gauze Dressings |
| PICO Negative Pressure Dressings | Experimental | In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. Receives: Device: PICO Single-Use Negative Pressure Dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study start20 Jul 2015
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Why it stopped: PI decided not to proceed with the major amendment and switching to the new generation of the device due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Of Bypass Graft of the ExtremitiesStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Siracuse, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492854
- Sponsor's protocol ID
- H-33618
- Acronym
- PICO-LEB
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2015
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
- ClinicalTrials.gov ID
- NCT02492854
- Acronym / sponsor ID
- PICO-LEB / H-33618
- Conditions
- Of Bypass Graft of the Extremities, Peripheral Arterial Disease, Vascular Diseases, Cardiovascular Diseases
- Keywords
- Lower Extremity Bypass, Surgical Site Infection, Wound Dressing, Negative Pressure Wound Dressing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decided not to proceed with the major amendment and switching to the new generation of the device due to lack of funding.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 20 Jul 2015 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Sterile Gauze Dressings | Active comparator | Other: Sterile Gauze DressingsIn this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. |
| PICO Negative Pressure Dressings | Experimental | Device: PICO Single-Use Negative Pressure DressingsIn this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICO Single-Use Negative Pressure DressingsNegative 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. | Device | PICO Negative Pressure Dressings |
| Sterile Gauze DressingsCurrent standard-of-care dressings used to cover surgical wounds post-operatively. | Other | Standard Sterile Gauze Dressings |
Primary outcome
Composite Score for Post-Operative Recovery
Time frame: 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.
1 secondary outcome
Function and Quality of Life Based on the Vascular Quality of Life Survey
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Siracuse, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO Single-Use Negative Pressure Dressings and Sterile Gauze Dressings in people with Of Bypass Graft of the Extremities and Peripheral Arterial Disease, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Score for Post-Operative Recovery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.