Wound Irrigation for Acne

Overseen By Vance Gardner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Must not be taking: Antibiotics, Cortisone

Disqualifiers: Under 18, Shoulder infection, others

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

Compensation: Varies

Number of Visits: 4

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two wound cleaning solutions, Irrisept (an antimicrobial wound lavage) and normal saline, to determine which more effectively reduces the presence of C. acnes, a bacteria often found in deep tissue. The study will also examine how these solutions impact patients' experiences and shoulder movement after surgery. Adult patients who need shoulder replacement surgery and have not had a shoulder infection or recent antibiotic treatment are eligible to participate. Participants will be divided into two groups, each receiving one of the solutions during their procedure. This research could improve surgical outcomes by identifying a better method for cleaning wounds. As an unphased trial, it offers patients the opportunity to contribute to research that may enhance surgical care and recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had antibiotic therapy within 2 weeks of surgery or cortisone infiltration within 3 months prior to surgery.

What prior data suggests that these irrigation methods are safe for wound treatment?

Research has shown that Irrisept Irrigation is safe and effectively stops bacterial growth while preserving important white blood cell activity. This means it cleans wounds without harming the body's natural defenses. Over 12 years of testing have supported its safety in both lab and real-life situations.

For Saline Irrigation, studies indicate it aids wound healing by cleaning the area and improving blood flow, suggesting it is generally safe and well-tolerated.

Both treatments have a long history of use, demonstrating safety for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these wound irrigation treatments for acne because they focus on a new method of delivering solutions directly into deep wounds, which could potentially improve healing outcomes. The Irrisept irrigation solution stands out because it contains a unique antiseptic component that might offer enhanced antibacterial effects compared to normal saline, which is commonly used but only provides a basic cleansing function. This trial aims to explore whether these irrigation methods can lead to better acne management by effectively reducing bacteria at multiple wound depths and time points, something that typical topical or oral acne treatments might not achieve as thoroughly.

What evidence suggests that this trial's treatments could be effective for acne?

Research has shown that Irrisept, containing a small amount of chlorhexidine (a germ-killer), effectively reduces bacteria, including C. acnes. Studies have found that using Irrisept results in fewer positive tests for C. acnes, suggesting it might outperform regular saline in reducing bacteria. In this trial, participants will join either the Irrisept irrigation arm or the Normal Saline Irrigation arm. Saline alone aids wound healing by cleaning and boosting blood flow. However, the addition of chlorhexidine in Irrisept provides extra bacteria-fighting power. This suggests that Irrisept might be more effective than saline alone for cleaning wounds and could improve healing for acne-related wounds. ^{1 2 3 4 6}

Who Is on the Research Team?

Hafiz F Kassam, MD

Principal Investigator

Hoag Orthopedics Education and Research

Are You a Good Fit for This Trial?

This trial is for individuals with wounds that need cleaning before surgery. Participants must be suitable for the study based on specific health criteria not detailed here.

Inclusion Criteria

I need a shoulder replacement surgery.

Exclusion Criteria

I have been diagnosed with rheumatoid arthritis.

I have had a shoulder infection in the past.

I have not had cortisone shots in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo total shoulder arthroplasty with either Normal Saline or Irrisept irrigation, and cultures are taken at multiple wound depths and time points.

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for C acnes presence, shoulder range of motion, and patient-reported outcomes.

24 months

Multiple visits at 3, 6, 12, and 24 months post-operation

What Are the Treatments Tested in This Trial?

Interventions

• Irrisept Irrigation
• Saline Irrigation Solution Delivery

Trial Overview The study aims to compare how effective two different wound cleaning solutions are at reducing bacteria in deep tissue: Normal Saline and Irrisept. It also looks at patient outcomes and joint movement after treatment.

How Is the Trial Designed?

Group I: Irrisept irrigation Arm (Group 2) Active Control 1 Intervention

After deep dissection, and prior to implantation of components, 100 cc of Irrisept solution will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.

Group II: Normal Saline Irrigation Arm (Group 1) Active Control 1 Intervention

After deep dissection, and prior to implantation of components, 100 cc of normal saline will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.

Irrisept Irrigation is already approved in United States for the following indications:

Approved in United States as Irrisept Antimicrobial Wound Lavage for:

• Mechanical cleansing and removal of debris, dirt, and foreign materials, including microorganisms from wounds

Who Is Running the Clinical Trial?

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Lead Sponsor

Trials

1

Recruited

130+

Irrimax Corporation

Industry Sponsor

Trials

11

Recruited

2,100+

Published Research Related to This Trial

Povidone-iodine at 10% concentration was found to be highly irritant to femoral arteries and veins in rats, causing damage to the vascular endothelium and leading to thrombosis.

Chlorhexidine at concentrations of 0.05%, 0.02%, and 0.001% showed very low toxicity, comparable to physiological saline, indicating it is a safer option for wound irrigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-toxic antiseptic irrigation with chlorhexidine in experimental revascularization in the rat. Severyns, AM., Lejeune, A., Rocoux, G., et al.[2022]

Nasal secretions from patients with chronic rhinosinusitis (CRS) showed reduced antimicrobial activity compared to healthy individuals, indicating a potential vulnerability in CRS patients' innate defenses.

Different formulations of nasal irrigation solutions can significantly impact the levels and effectiveness of antimicrobial peptides, with isotonic solutions temporarily lowering these levels, while low-salt solutions initially decrease activity but later stimulate peptide secretion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of nasal irrigation formulation on the antimicrobial activity of nasal secretions. Woods, CM., Tan, S., Ullah, S., et al.[2016]

In a study involving 12 inpatients with 18 leg ulcers, isotonic saline irrigation using a special dressing led to faster wound healing compared to conventional saline dressings, as indicated by quicker fibrin crust disappearance and granulation tissue formation.

The use of isotonic saline irrigation also resulted in earlier increases in wound blood flow, although the rate of wound contraction was similar between both treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irrigation treatment of leg ulcers. Svedman, P.[2022]

In a study involving 36 healthy subjects, both iodine povacrylex and chlorhexidine gluconate significantly reduced bacterial density on the skin after application, indicating their effectiveness as skin antiseptics.

However, while chlorhexidine was largely removed by saline exposure, the iodine povacrylex formed a water-insoluble film that remained intact, suggesting it may provide longer-lasting antimicrobial protection during surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance of antimicrobial skin preparations to saline rinse using a seeded bacteria model. Stahl, JB., Morse, D., Parks, PJ.[2017]

In a study involving 32 male rats with infected surgical wounds, the group treated with PVP-I (Group D) showed an inflammatory response similar to the untreated control group, indicating that PVP-I may not effectively reduce inflammation in infected wounds.

The saline solution group (Group B) exhibited the most severe inflammatory response, while chlorhexidine (Group C) resulted in a moderate response, suggesting that the choice of wound cleaning solution significantly impacts the inflammatory response post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphological analysis of three wound-cleaning processes on potentially contamined wounds in rats. d'Acampora, AJ., Vieira, DS., Silva, MT., et al.[2019]

Irriclens is the first aerosol wound cleanser, offering a sterile 0.9% sodium chloride solution that can effectively cleanse and irrigate wounds, potentially improving convenience and ease of use.

This product may be more cost-effective than traditional antiseptics, as it minimizes waste and reduces the need for additional equipment during wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irriclens: a sterile wound cleanser in an aerosol can. Williams, C.[2015]

In a study involving 631 catheters in an intensive care unit, both 0.5% alcoholic chlorhexidine gluconate and 2% aqueous chlorhexidine gluconate were found to be significantly more effective than 10% aqueous povidone iodine in preventing catheter colonization, particularly against gram-positive bacteria.

There was no significant difference in effectiveness between the two chlorhexidine solutions, indicating that either can be used effectively for skin antisepsis prior to catheter insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective randomized trial of 3 antiseptic solutions for prevention of catheter colonization in an intensive care unit for adult patients. Vallés, J., Fernández, I., Alcaraz, D., et al.[2017]

In a study involving 55 patients who underwent sinonasal surgery, both povidone-iodine (PVP-I) and normal saline nasal irrigation showed significant improvements in nasal symptoms and function three months post-surgery.

However, there was no additional benefit of using 0.1% PVP-I nasal irrigation over normal saline, indicating that saline may be just as effective for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Povidone-Iodine Nasal Irrigation Solution After Sinonasal Surgery: A Randomized Controlled Study. Wu, PH., Cheng, PC., Chang, CM., et al.[2022]

In an in-vitro study using human plasma as a wound coating, saline and Ringer's solutions, along with a betaine surfactant solution, effectively removed harmful protein coatings from wounds, which is crucial for promoting healing.

In contrast, an antiseptic solution (Octenisept) caused the wound coatings to become fixed and insoluble, potentially hindering the healing process and increasing the risk of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-vitro test for comparing the efficacy of wound rinsing solutions. Kaehn, K., Eberlein, T.[2014]

Bacitracin and Clorpactin were found to be damaging to human osteoblast cells in vitro, but the damage was at least partially reversible, as cells returned to normal morphology after a week.

Irrisept (chlorhexidine) caused the most significant and irreversible damage to osteoblasts, indicating it may not be a safe option for irrigation during joint surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. Markel, JF., Bou-Akl, T., Dietz, P., et al.[2022]

In a study involving 20 subjects, sodium hypochlorite (SH) was found to be the most irritating antiseptic, leading to its discontinuation after just 4 applications due to severe irritation, while iodine in ethanol (IE) also caused significant irritation after 7 applications.

Chlorhexidine (4% and 0.5% in ethanol), ethanol (70%), and povidone-iodine (10%) were determined to be non-irritating after 8 applications, indicating they are safer options for antiseptic use in this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritancy of antiseptics tested by repeated open exposures on the human skin, evaluated by non-invasive methods. Tupker, RA., Schuur, J., Coenraads, PJ.[2019]

Citations

1. withpower.com withpower.com/trial/phase-wounds-and-injuries-2-2024-507a8

Wound Irrigation for Acne Research shows that using saline irrigation, similar to the Irrisept treatment, can improve wound healing by promoting faster cleansing and increased blood flow ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11509154/

Assessing the Effects of Surgical Irrigation Solutions on ... Irrisept combined effective inhibition of bacterial growth while maintaining neutrophil viability and motility. These diverse outcomes suggest ...

3. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00841-3/fulltext

Effect of antiseptic irrigation with 0.05% chlorhexidine ... This study was designed to investigate whether intraoperative Irrisept irrigation would result in a lower positive culture rate of C. acnes vs. standard ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1058274625002654

Subcutaneous lavage with a 0.05% chlorhexidine ... The use of a 0.05% CHG irrigation solution in the subcutaneous layer leads to a significantly decreased rate of positive deep cultures of C acnes in TSA.

5. irrisept.com irrisept.com/

Irrisept: Home Irrisept antimicrobial wound lavage is a self-contained jet lavage with low concentration CHG as a preservative in the bottled solution.

6. irrisept.com irrisept.com/research/

Research Irrisept features an extensive safety profile with in-vitro and in-vivo studies and RCT data, with >12 years of proven history and testing.