Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 7/13/2018 |
| Start Date: | July 2015 |
| End Date: | June 2020 |
| Contact: | Jeffrey Siracuse, MD |
| Email: | Jeffrey.Siracuse@bmc.org |
| Phone: | 617-638-8488 |
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.
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.
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.
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.
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
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