Adding EDTlo (Procellera®) for 3 weeks after use of EDThi for Wounds

Phase-Based Estimates
1
Effectiveness
1
Safety
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Wounds+1 More
Adding EDTlo (Procellera®) for 3 weeks after use of EDThi - Device
Eligibility
18+
All Sexes
Eligible conditions
Wounds

Study Summary

Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

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Eligible Conditions

  • Wounds
  • Wounds and Injuries
  • Wound Healing

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Adding EDTlo (Procellera®) for 3 weeks after use of EDThi will improve 1 primary outcome and 3 secondary outcomes in patients with Wounds. Measurement will happen over the course of 3 weeks.

3 weeks
wound microbiome in SoC and SoC+ EDT treatment.
6 weeks
Percent of patients with response to EDT treatment on week 6 as compared to SoC only group
Response to the use of EDT treatment in prevention of wound biofilm infection
rate of wound closure 6 weeks post-treatment as compared to baseline

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
SOC and PED-10 +Procellera

This trial requires 112 total participants across 2 different treatment groups

This trial involves 2 different treatments. Adding EDTlo (Procellera®) For 3 Weeks After Use Of EDThi is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

SOC and PED-10 +ProcelleraIn group 2, in addition to SoC, the patients will apply the EDThi dressing (PED-10) on the wound(s) for the first 3 weeks following enrollment followed by Procellera® or EDTlo for additional 3 weeks. The use of dressings will be discontinued anytime if complete wound closure is achieved.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 weeks for reporting.

Who is running the study

Principal Investigator
S. R.
Prof. Sashwati Roy, Professor of Surgery
Indiana University

Closest Location

Richard L. Roudebush VA Medical Center - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Any patient with a wound below the knee must have adequate wound tissue oxygenation as determined by one or more of the following perfusion values within 6 months on enrollment: peri-wound transcutaneous oxygen measurements ≥ 25 mmHg (TCOM),Ankle Brachial Index (ABI) >0.7, or a Toe pressure (TP) > 40 mmHg show original
Ages 18 years and older
subjects willing and able to provide informed consent
People who have chronic trauma or surgical wounds that are infected. show original
The wound(s) must be able to be covered by the EDT dressing so that the dressing can absorb the blood and protect the wound. show original
Those who want to be subjects in this study must be able to read and understand English. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is wounds?

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Recent findings provides new information regarding age-related changes in cutaneous structure and function. This information is critical for development of effective wound care in the elderly.

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What causes wounds?

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Wounds can have many causes. In those with poor hygiene, their wounds often fail to heal. Clean wounds heal easily, even when covered by dirt and infection.

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Can wounds be cured?

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In a recent study, findings suggests that the healing of a normal wound may be an effective therapeutic end point, especially in a wound model treated with a potentiating agent such as N-acetylcysteine or glutathione and in a time period which allows for the administration of a potentiator.

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What are common treatments for wounds?

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Common treatment for wounds consists of topical saline and dressings, skin grafts, and wound closure (e.g., sutures). These are the basic wounds management. However, surgical procedures and reconstructive reconstructive procedures are used for more complex wounds.

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How many people get wounds a year in the United States?

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In a one-year period, 8.4 million wounds were encountered. Most of these wounds were superficial in nature, necessitating less costly and fewer hospital admissions. In a one-year period, a wound clinic could save $4.8 million by reducing the average length of stay for patients with wounds. Further, a wound clinic may be able to reduce hospital admissions by as many as 21%.

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What are the signs of wounds?

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Patients need to be informed about the signs and symptoms of wounds. The signs and symptoms of wounds vary depending on the type of wound (e.g., wound of the skin and a wound on the nose). The signs of wound should not be delayed for any other reason than the time needed for diagnosis. Wound drainage should be started immediately after admission, which will help speed-up the healing process.

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Who should consider clinical trials for wounds?

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Wounds is an exciting topic for consideration. However, the question to be asked is not just ‘is my wound a good wound’ but also ‘is my wound responsive to a particular treatment’. A trial comparing a particular topical treatment with a standard treatment would not be sufficient as the patient’s response will determine the need for more or different treatment. The outcome of the first trial may reveal the patient’s response to the treatment.

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What is the latest research for wounds?

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This article provides a summary of the latest research findings on wound care in developing countries. For appropriate wound management, the key factors are to ensure patient compliance, to ensure a clean, sterile environment, to ensure adequate access to dressing materials and to use appropriate dressings; there is insufficient evidence to recommend or exclude any single dressing for wounds in developed countries.

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What are the common side effects of adding edtlo (procellera®) for 3 weeks after use of edthi?

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This open-label study demonstrated acceptable safety in the long term follow-up period (3 months) of adding procellera after EDT use. No safety concern was noted in the form of severe symptoms or serious adverse events. Recent findings is the first to show that the safety of adding procellera after a course of EDT or EDT-S has been demonstrated.

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What are the latest developments in adding edtlo (procellera®) for 3 weeks after use of edthi for therapeutic use?

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Procellera® is efficacious in the treatment of moderate to severe cases of edthi-induced skin reactions. This option should be explored further in order to reduce the number and severity of skin reactions seen in edthi users.

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Has adding edtlo (procellera®) for 3 weeks after use of edthi proven to be more effective than a placebo?

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Adding edtlo to usual topical antibiotic therapy after 1 week in patients with acute wound infection increased infection cure rate compared to patients who received an edtlo placebo. This may reflect a role for edtlo as an effective adjuvant in the management of wound infection.

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Is adding edtlo (procellera®) for 3 weeks after use of edthi safe for people?

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Edtlo is not superior to chlorhexidine (2% HCl) alone. There were no appreciable advantages of adding edtlo to chlorhexidine (2% HCl) during the first 3 weeks after use. There is no reason to recommend long-term use of edtlo.

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