Standard Versus PICO Dressings in Lower-Extremity Bypass Patients

Not Applicable

Terminated

Conditions: Of Bypass Graft of the Extremities
Vascular Diseases
Cardiovascular Diseases
Peripheral Arterial Disease

Interventions: Other: Sterile Gauze Dressings
Device: PICO Single-Use Negative Pressure Dressings

Registration Number: NCT02492854

Lead Sponsor: Boston Medical Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Sterile Gauze Dressings	Sterile Gauze Dressings	In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.
PICO Negative Pressure Dressings	PICO Single-Use Negative Pressure Dressings	In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.

Primary Outcome Measures

Name	Time	Method
Composite Score for Post-Operative Recovery	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Function and Quality of Life Based on the Vascular Quality of Life Survey	1 year	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.