PICO-LEB: Standard Versus PICO Dressings in Lower-Extremity Bypass Patients

• Sponsor: Boston Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02492854
• Collaborator: Smith & Nephew, Inc. (Industry)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 66.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
• Actual Study Start Date: Jul 20, 2015
• Actual Primary Completion Date: Jan 20, 2021
• Actual Study Completion Date: Jan 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Resource Utilization in Dollars [Composite Measure] [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston Medical Center
• Smith & Nephew, Inc.

Investigators

• Principal Investigator: Jeffrey Siracuse, MD, Boston Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 26, 2015

More Information

Publications

None provided.

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT02492854
• Other Study ID Numbers: H-33618
• First Posted: Jul 9, 2015
• Last Update Posted: Nov 4, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Boston Medical Center: Lower Extremity Bypass; Surgical Site Infection; Wound Dressing; Negative Pressure Wound Dressing
• Additional relevant MeSH terms: Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases

Study Results

Participant Flow

Arm/Group Title	Standard Sterile Gauze Dressings	PICO Negative Pressure Dressings
Arm/Group Description	In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively.	In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. 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 surgical-site infections (SSIs) post-lower extremity (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.
Period Title: Overall Study
STARTED	5	3
COMPLETED	5	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard Sterile Gauze Dressings	PICO Negative Pressure Dressings	Total
Arm/Group Description	In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively.	In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. 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.	Total of all reporting groups
Overall Participants	5	3	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.4 (8.3)	60.3 (12.1)	60.4 (9.0)
Sex: Female, Male (Count of Participants)
Female	1 20%	1 33.3%	2 25%
Male	4 80%	2 66.7%	6 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	5 100%	3 100%	8 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 20%	2 66.7%	3 37.5%
White	4 80%	1 33.3%	5 62.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%	3 100%	8 100%

Outcome Measures

1. Primary Outcome

Title	Composite Score for Post-Operative Recovery
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Sterile Gauze Dressings	PICO Negative Pressure Dressings
Arm/Group Description	In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively.	In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. 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.
Measure Participants	5	3
Mean (Standard Deviation) [scores on a scale]	0.80 (0.45)	0.33 (0.58)

2. Secondary Outcome

Title	Function and Quality of Life Based on the Vascular Quality of Life Survey
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

For the Standard Sterile Gauze Dressing arm, data were not collected for 3 of the 5 participants as the study was terminated before 1 year of follow-up for those participants.

Arm/Group Title	Standard Sterile Gauze Dressings	PICO Negative Pressure Dressings
Arm/Group Description	In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively.	In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. 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.
Measure Participants	2	3
Mean (Standard Deviation) [scores on a scale]	121.50 (7.78)	144.67 (6.66)

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

Since the study was terminated, this outcome measure was not assessed for any of the participants.

Arm/Group Title	Standard Sterile Gauze Dressings	PICO Negative Pressure Dressings
Arm/Group Description	In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively.	In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. 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.
Measure Participants	0	0

Adverse Events

Time Frame	12 months
Arm/Group Title	Standard Sterile Gauze Dressings		PICO Negative Pressure Dressings
Arm/Group Description	In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively. Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively.		In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings. 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.
All Cause Mortality
	Standard Sterile Gauze Dressings		PICO Negative Pressure Dressings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/3 (0%)
Serious Adverse Events
	Standard Sterile Gauze Dressings		PICO Negative Pressure Dressings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/5 (60%)		1/3 (33.3%)
Cardiac disorders
Acute chest pain	1/5 (20%)	1	0/3 (0%)	0
Infections and infestations
Surgical Site Infection	0/5 (0%)	0	1/3 (33.3%)	1
Infected bypass graft	0/5 (0%)	0	1/3 (33.3%)	1
Skin and subcutaneous tissue disorders
Cellulitis	1/5 (20%)	1	0/3 (0%)	0
Hematoma	0/5 (0%)	0	1/3 (33.3%)	1
Abcess	1/5 (20%)	1	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	Standard Sterile Gauze Dressings		PICO Negative Pressure Dressings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/5 (60%)		1/3 (33.3%)
Infections and infestations
Fever	0/5 (0%)	0	1/3 (33.3%)	1
Serosanguisous discharge	0/5 (0%)	0	1/3 (33.3%)	1
Redness and swellig	1/5 (20%)	1	0/3 (0%)	0
Psychiatric disorders
Altered mental status	0/5 (0%)	0	1/3 (33.3%)	1
Skin and subcutaneous tissue disorders
Cellulites	1/5 (20%)	1	0/3 (0%)	0
Vascular disorders
Peripheral arterial disease	1/5 (20%)	1	0/3 (0%)	0

Limitations/Caveats

The Covid pause halted participant enrollment and the PI decided not to proceed with the major amendment and switching to the new generation of the device due to lack of funding. This resulted in study termination, a small number of subjects for analysis, and incomplete data collection for the outcome measure designed to be collected at 1 year.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.