Standard Versus PICO Dressings in Lower-Extremity Bypass Patients (PICO-LEB)
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|ClinicalTrials.gov Identifier: NCT02492854|
Recruitment Status : Suspended (Currently suspended due to Covid-19 pollicies.)
First Posted : July 9, 2015
Last Update Posted : May 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Of Bypass Graft of the Extremities Peripheral Arterial Disease Vascular Diseases Cardiovascular Diseases||Device: PICO Single-Use Negative Pressure Dressings Other: Sterile Gauze Dressings||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Standard Versus PICO Dressings in Lower-Extremity Bypass Patients|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Standard Sterile Gauze Dressings
In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.
Other: Sterile Gauze Dressings
Current standard-of-care dressings used to cover surgical wounds post-operatively.
Experimental: PICO Negative Pressure Dressings
In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.
Device: 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.
- Infection of Surgical Site Incision [composite measure] [ Time Frame: 30 days ]The primary endpoint is lower-extremity bypass post-operative recovery that is free of major complications. We will be measuring leg swelling, days to ambulation, and rates of infection, to be defined as clinician prescribing antibiotics..
- Function and Quality of Life via the Vascular Quality of Life Survey [composite measure] [ Time Frame: 1 year ]Subjects will be evaluated for independent living, ambulatory status, and quality of life (QoL) and functional assessments using the Vascular Quality of Life (VascuQol) survey.
- Resource Utilization in Dollars [composite measure] [ Time Frame: 1 year ]Length of stay and discharge to rehabilitation centers will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492854
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Jeffrey Siracuse, MD||Boston Medical Center|