Clinical trial NCT02492854: Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
Official title: Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2015-07-09
Enrollment: 8
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Score for Post-Operative Recovery
timeFrame: 30 days
Secondary outcomes:
measure: Function and Quality of Life Based on the Vascular Quality of Life Survey
timeFrame: 1 year
Other outcomes:
measure: Resource Utilization in Dollars [Composite Measure]
timeFrame: 1 year
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jeffrey Siracuse, MD
role: PRINCIPAL_INVESTIGATOR
References: