Wound Irrigation for Acne

Recruiting in Palo Alto (17 mi)

Overseen by Hafiz F Kassam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Must not be taking: Antibiotics, Cortisone

Disqualifiers: Under 18, Shoulder infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.

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 data supports the effectiveness of the treatment Irrisept 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, which may suggest potential benefits for acne treatment as well. ^{1 2 3 4 5}

Is wound irrigation with saline solution safe for humans?

Research indicates that saline solution, used for wound irrigation, is generally safe and non-toxic for humans. It is often used as a sterile solution for cleansing wounds and has been found to have low toxicity comparable to other antiseptic solutions. ^{1 6 7 8 9}

How is the Irrisept Irrigation treatment for acne different from other treatments?

Irrisept Irrigation is unique because it uses a sterile saline solution for wound cleansing, which is gentle and helps remove harmful coatings without causing damage, unlike traditional antiseptics that can fix and make wound coatings insoluble. This approach is cost-effective and reduces the need for additional equipment, making it a novel option for treating acne. ^{1 2 9 10 11}

Research Team

Hafiz F Kassam, MD

Principal Investigator

Hoag Orthopedics Education and Research

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Irrisept Irrigation (Procedure)
• Saline Irrigation Solution Delivery (Procedure)

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.

Participant Groups

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.

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Irrigation treatment of leg ulcers. [2022]

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

Resistance of antimicrobial skin preparations to saline rinse using a seeded bacteria model. [2017]

4. Brazil pubmed.ncbi.nlm.nih.gov

Morphological analysis of three wound-cleaning processes on potentially contamined wounds in rats. [2019]

5. United States 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. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Non-toxic antiseptic irrigation with chlorhexidine in experimental revascularization in the rat. [2022]

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

The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Irritancy of antiseptics tested by repeated open exposures on the human skin, evaluated by non-invasive methods. [2019]

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

The effect of nasal irrigation formulation on the antimicrobial activity of nasal secretions. [2016]

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

Efficacy of Povidone-Iodine Nasal Irrigation Solution After Sinonasal Surgery: A Randomized Controlled Study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

In-vitro test for comparing the efficacy of wound rinsing solutions. [2014]