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

Trial Summary

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 data supports the effectiveness of the PICO dressing treatment 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 reopening in various surgeries, including lower extremity amputations. This suggests it may help improve recovery after total ankle replacement by promoting better wound healing. ^{1 2 3 4 5}

Is the PICO dressing generally safe for use in humans?

The PICO dressing has been used in various surgeries and wound treatments, and studies suggest it is generally well accepted by patients. Some concerns include fear of dropping the pump and initial uncertainty, but no major safety issues have been reported. ^{1 2 3 4 5}

How is the PICO dressing treatment different from other treatments for total ankle replacement recovery?

The PICO dressing is a unique treatment because it uses negative pressure wound therapy (NPWT) to help heal surgical wounds by reducing complications like infections and wound dehiscence (wound reopening). It is a portable, single-use system that requires fewer dressing changes compared to traditional methods, making it more convenient for outpatient care. ^{1 2 3 4 5}

What is the purpose of this trial?

To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.

Research Team

Walter C Hembree, MD

Principal Investigator

MedStar Health

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Specific Single-Use Incisional Negative Pressure Wound Therapy (PICO System) After Major Lower Extremity Amputation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Patients' Experiences Using Closed Incision Negative Pressure Wound Therapy Dressing After Infra-Inguinal Vascular Surgery. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Negative pressure therapy for stoma closure sites-a nonrandomised case control study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Negative Pressure Dressings (PICOTM) on Laparotomy Wounds Do Not Reduce Risk of Surgical Site Infection. [2021]