Standard Versus PICO Dressings in Lower-Extremity Bypass Patients

NCT ID: NCT02492854

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-20
• Study Completion Date: 2021-01-20

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.

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Sterile Gauze Dressings

In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.

Group Type: ACTIVE_COMPARATOR

Sterile Gauze Dressings

Intervention Type: OTHER

Current standard-of-care dressings used to cover surgical wounds post-operatively.

PICO Negative Pressure Dressings

In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.

Group Type: EXPERIMENTAL

PICO Single-Use Negative Pressure Dressings

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Sterile Gauze Dressings

Current standard-of-care dressings used to cover surgical wounds post-operatively.

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Siracuse, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-33618

Identifier Type: -

Identifier Source: org_study_id