PICO Dressing for Total Ankle Replacement Recovery

Recruiting at 1 trial location

Overseen By Amy Loveland

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Walter C Hembree

Disqualifiers: Deep infection, Wound complication, Allergy, Pregnancy, Poor compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 7 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a PICO dressing, a type of negative pressure wound therapy system, compared to standard nonstick gauze in healing wounds from ankle replacement surgery. The goal is to determine which dressing better prevents wound complications. Individuals who have undergone ankle replacement surgery and can adhere to the study schedule might be suitable candidates. The trial includes one group using the PICO dressing and another using standard gauze for comparison. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance post-surgical care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PICO dressing is safe for wound recovery?

Research has shown that the PICO dressing, a type of wound care treatment, effectively reduces complications like infections. One study found that patients using PICO experienced fewer wound problems after surgery. Another source suggested that using PICO for ankle surgeries lowers the chance of wound complications and infections.

These findings suggest that patients generally tolerate the PICO dressing well. While the rate of wound infections can vary, evidence indicates that PICO is a safe option for managing wounds after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PICO dressing for total ankle replacement recovery because it offers a novel approach to wound care by providing negative pressure wound therapy (NPWT). Unlike the standard non-stick gauze dressing, which simply covers the wound, the PICO dressing actively promotes healing by removing excess fluid and reducing swelling. This mechanism can potentially speed up recovery time and minimize complications, making it an innovative alternative to traditional dressings.

What evidence suggests that the PICO dressing is effective for reducing wound complications in total ankle replacement recovery?

Research has shown that PICO dressings, which use Negative Pressure Wound Therapy (NPWT), can speed up healing after surgeries, including bone surgeries. In one study, all patients healed successfully with this dressing, even those who typically take longer to heal. Another study found that using a portable NPWT device immediately after ankle surgery proved beneficial. This trial will compare two groups: one will have their surgical wound covered with standard non-stick gauze, while the other will use the PICO dressing. The PICO dressing works by gently suctioning to remove fluids and support healing. While further research is always valuable, these findings suggest that PICO dressings could enhance recovery after ankle replacement surgery. ^{1 2 4 5 6}

Who Is on the Research Team?

Walter C Hembree, MD

Principal Investigator

MedStar Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent to participate, understand the study's procedures, and are having a total ankle replacement or revision. It's not for those with allergies to study products, past deep infections or wound issues requiring plastic surgery, pregnant or breastfeeding women, people with poor medical treatment compliance history, prisoners.

Inclusion Criteria

Subjects able to provide informed consent

Subjects who are able to understand and comply with study visit schedule and procedures

I am having or have had a total ankle replacement or a simple revision of one.

Exclusion Criteria

Allergy to products used in the study

Pregnant and breastfeeding women due to anesthesia risks

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anterior total ankle arthroplasty and receive either a standard non-stick gauze dressing or a PICO dressing

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for wound complications and assessed through follow-up visits

12 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PICO dressing

Trial Overview The trial is testing if a PICO dressing—a single-use negative pressure therapy system—reduces wound complications better than standard non-stick gauze after total ankle arthroplasty (ankle replacement surgery).

How Is the Trial Designed?

Group I: Group 2 (Treatment group) Experimental Treatment 1 Intervention

Surgical wound will be covered with the PICO dressing.

Group II: Group 1 (Control group) Active Control 1 Intervention

Surgical wound will be covered with the standard non-stick gauze dressing.

PICO dressing is already approved in United States, European Union, Japan for the following indications:

Approved in United States as PICO Single Use Negative Pressure Wound Therapy System for:

• Chronic wounds
• Acute wounds
• Traumatic wounds
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions

Approved in European Union as PICO dressing for:

• Closed surgical incisions
• Orthopaedic and obstetric surgery

Approved in Japan as PICO dressing for:

• Closed surgical incisions

Who Is Running the Clinical Trial?

Walter C Hembree

Lead Sponsor

Trials

1

Recruited

150+

Smith & Nephew, Inc.

Industry Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Published Research Related to This Trial

In a study involving 188 moderate-risk patients undergoing laparotomy, the use of PICO dressings did not significantly reduce the rate of surgical site infections compared to standard dressings, with 14% of patients in both groups developing infections.

While there was a trend towards fewer overall surgical site complications in the PICO group (11 complications) compared to the standard dressing group (20 complications), this difference was not statistically significant, suggesting that PICO dressings may not provide a clear benefit in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure Dressings (PICOTM) on Laparotomy Wounds Do Not Reduce Risk of Surgical Site Infection. Flynn, J., Choy, A., Leavy, K., et al.[2021]

The PICO™ dressing, which uses negative pressure wound therapy, was generally well accepted by patients after vascular surgery, indicating its potential effectiveness in reducing surgical site infections.

Patients reported some concerns, such as fear of dropping the pump and a lack of information, but those who used both the PICO™ and standard dressings preferred the PICO™ dressing, suggesting a positive patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences Using Closed Incision Negative Pressure Wound Therapy Dressing After Infra-Inguinal Vascular Surgery. Nyman, J., Acosta, S., Monsen, C., et al.[2022]

Patients with stoma closure wounds treated with the PICO dressing required significantly fewer visits to community nurses (1.9 visits) compared to those with traditional packing (11.9 visits), indicating improved convenience and potentially better management of the wound.

The majority of patients using the PICO dressing were able to return to work or daily activities within 1 to 2 weeks, suggesting that this negative pressure wound therapy may enhance recovery times for stoma closure wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure therapy for stoma closure sites-a nonrandomised case control study. Obeid, N., Sharma, E., Dunstan, M., et al.[2021]

The PICO negative pressure wound therapy (NPWT) dressing was successfully used on 21 patients with various postoperative or posttraumatic wounds, demonstrating effective healing with a median treatment duration of 16 days.

Using the PICO dressing in an outpatient setting not only improved patient care by promoting faster healing but also saved hospital costs by reducing the need for inpatient stays, totaling 24 bed days saved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the Single Use Negative Pressure Wound Therapy Device (PICO) on a Heterogeneous Group of Surgical and Traumatic Wounds. Payne, C., Edwards, D.[2022]

The use of the PICO system for incisional negative-pressure wound therapy after lower extremity amputation (LEA) showed a lower incidence of postoperative wound complications, such as surgical site infections (SSIs) and wound dehiscence, compared to conventional dressings (12.5% vs 43.8%).

No cases of deep SSIs were reported in the PICO dressing group, indicating its potential effectiveness in enhancing wound management outcomes, despite the study's limitations of being retrospective and having a small sample size of 32 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Specific Single-Use Incisional Negative Pressure Wound Therapy (PICO System) After Major Lower Extremity Amputation. Takahashi, H., Takeda, S., Tanaka, Y., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03886818

Efficacy of Negative Pressure Wound Therapy After Total ... Incisional NPWT can accelerate wound healing regardless of the surgery performed, including orthopedics. A retrospective study compared the incidence of healing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12040113/

Incisional Negative Pressure Wound Therapy devices applied ... A portable, single-use incisional Negative Pressure Wound Therapy (iNPWT) device could be used directly on the wound incision following Total Ankle ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7362643/

The Use of Closed Incision Negative Pressure Therapy ... This retrospective case series demonstrated 100% healing with the utilization of the ciNPT in both normal and high-risk patients with decreased healing ...

4. possiblewithpico.com possiblewithpico.com/sites/default/files/picoImages/documents/resources/PCME16-42080-0424-Evidence%20in%20focus%20clinical%20compendium-FINAL%20APPROVED.pdf

PICO◊ sNPWT clinical compendium PICO sNPWT is indicated for patients who would benefit from a suction device (NPWT) as it may promote wound healing via removal of low to moderate levels of ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05064696?keyword=%22Arthroplasty%22

PICO- Single-use Negative Pressure Wound Therapy System If randomized to Group 2- after surgery, the doctor will apply the PICO dressing to the wound.~The goal of the study is to measure the rate of wound ...

6. withpower.com withpower.com/trial/phase-7-2021-c741a

PICO Dressing for Total Ankle Replacement Recovery Research shows that the PICO dressing, a type of negative pressure wound therapy, has been effective in reducing complications like infections and wound ...