72 Participants NeededMy employer runs this trial

Hypochlorous Acid for Pilonidal Disease

EH
EO
Overseen ByElton Ortiz, MS
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best method for cleaning wounds during surgery for individuals with Stage 3 pilonidal disease, a painful skin condition near the tailbone. Researchers compare the usual cleaning solution, saline, with hypochlorous acid to determine which promotes faster wound healing. Individuals diagnosed with Stage 3 pilonidal disease who can consent to participate may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this method is safe for wound cleaning during surgery?

Research has shown that hypochlorous acid is generally safe for cleaning wounds. In studies where researchers used it, infections cleared up within two weeks, and wound samples showed no bacteria. The size of these wounds decreased by more than 90% after treatment. Additionally, no reports of negative effects have emerged when animals were exposed to hypochlorous acid in other situations. This suggests that the treatment is well-tolerated and safe for cleaning wounds during surgery.12345

Why are researchers excited about this trial?

Researchers are excited about using hypochlorous acid for treating pilonidal disease because it offers a novel approach compared to the standard saline solution. Hypochlorous acid is known for its potent antimicrobial properties, which can enhance wound cleaning by effectively reducing bacteria and preventing infection. This could lead to faster healing times and better outcomes for patients, which is a significant improvement over traditional methods. By using a solution that not only cleans but also actively fights infection, this treatment has the potential to provide a more efficient and effective care option for those suffering from pilonidal disease.

What evidence suggests that hypochlorous acid is effective for pilonidal disease?

Research has shown that hypochlorous acid can aid in healing surgical wounds. One study demonstrated that it cleared infections in two weeks and reduced wound size by more than 90%. Another study found that using hypochlorous acid to clean wounds is both affordable and safe at low levels. In this trial, one group of participants will receive hypochlorous acid for wound irrigation, while another group will receive saline, the current standard of care. These findings suggest that hypochlorous acid could be beneficial for wound healing, particularly in challenging cases like pilonidal disease.12456

Who Is on the Research Team?

BC

Bill Chiu, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for people with stage 3 pilonidal disease who are having surgery. Participants must meet the specific criteria for this stage of the condition, based on the Stanford Pilonidal Severity Staging System.

Inclusion Criteria

My pilonidal disease is classified as stage 3 severity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants undergo surgery with intraoperative wound irrigation using either saline or hypochlorous acid solution

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for wound healing using photographs on postoperative days 0, 2, 5, 7, 10, and 14, and then weekly until wound closure

2-4 weeks
Photographs submitted remotely

Follow-up

Participants are monitored for recurrence of pilonidal disease at the original surgical site

2 years
Clinic visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Hypochlorous Acid

Trial Overview

The study compares two wound cleaning solutions used during surgery: standard saline versus hypochlorous acid (Vashe). The goal is to see which solution helps wounds heal better and faster after pilonidal disease surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: VasheExperimental Treatment1 Intervention
Group II: SalineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

The Use of Hypochlorous Acid Lavage to Treat Infected Cavity ...

The infection had cleared within 2 weeks, and a swab culture found no microbial growth. The wound volume was reduced by more than 90% after 5 ...

Intraoperative Wound Irrigation for Pilonidal Disease

This study will evaluate whether irrigating the surgical wound with hypochlorous acid solution (Vashe, Urgo Medical) during excision of Stage 3 ...

Hypochlorous Acid for Pilonidal Disease · Info for Participants

The purpose of this study is to determine the best method for cleaning wounds during surgery for patients with Stage 3 pilonidal disease.

Intraoperative Wound Irrigation for Pilonidal Disease

The purpose of this study is to determine the best method for cleaning wounds during surgery for patients with Stage 3 pilonidal disease. The investigators will ...

Comparing the Efficacy and Rates of Adverse Outcomes ...

Their results demonstrated that hypochlorous acid does not lead to an increase in the corrosion current at lower concentrations (5 mM), but it can lead to ...

Wound Infection After Cleft Lift Operation for Pilonidal ...

This article discusses an approximate 10-year experience with infections after the cleft lift procedure in a busy pilonidal practice.