Standard Versus PICO Dressings in Lower-Extremity Bypass Patients (PICO-LEB)

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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Of Bypass Graft of the Extremities
• Intervention / Treatment: Other: Sterile Gauze Dressings; Device: PICO Single-Use Negative Pressure Dressings

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource Utilization in Dollars [Composite Measure]	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.	1 year

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Jeffrey Siracuse, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2015
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Wound Dressing; Lower Extremity Bypass; Negative Pressure Wound Dressing
• Additional Relevant MeSH Terms: Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Cardiovascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: H-33618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes