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Ethanol (96 Per Cent)

This article explores the use of Ethanol (96 Per Cent) in clinical trials aimed at optimizing skin preparation for shoulder surgery in male patients. The focus is on reducing Cutibacterium acnes colonization, a common cause of infection in shoulder arthroplasty. The study compares different skin preparation methods, including the use of alcoholic iodine povidone solution containing Ethanol (96 Per Cent), to improve surgical outcomes and reduce infection rates.

Table of Contents

What is ETHANOL (96 PER CENT)?

ETHANOL (96 PER CENT) is a form of highly concentrated alcohol. It’s also known by several other names, including:

  • Alcohol (96%)
  • Ethanol 96%
  • Ethyl alcohol 96%
  • Ethanol 96% (V/V)
This substance is commonly used in medical settings for its antiseptic properties, meaning it can kill or slow the growth of microorganisms on the skin.[1]

Medical Use in Shoulder Surgery

In the context of shoulder surgery, ETHANOL (96 PER CENT) is being studied as part of a skin preparation solution. It’s combined with another substance called povidone-iodine to create an antiseptic solution. This combination is used to clean the skin before surgery to reduce the risk of infection.[1]

Clinical Trial: OPRICA Study

A clinical trial called OPRICA (Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients) is currently studying the use of this ethanol-based solution. The main goals of this study are:

  1. To evaluate how effective a 5% alcoholic iodine povidone solution is at reducing bacteria on the skin before shoulder surgery.[1]
  2. To compare this method with another approach using a different substance called benzoyl peroxide.[1]
The study focuses on a specific type of bacteria called Cutibacterium acnes, which is commonly found on human skin and can cause infections after shoulder surgery.[1]

Application and Dosage

In the OPRICA study, the ethanol-based solution (BETADINE ALCOOLIQUE 5%) is applied to the skin just before surgery. It’s used as a single-dose cutaneous solution, which means it’s applied directly to the skin in the area where the surgery will be performed.[1]

Patient Eligibility

The study is specifically looking at male patients who are having shoulder surgery. Some key eligibility criteria include:

  • Patients without a history of previous shoulder surgery on the operated shoulder
  • Patients undergoing specific types of shoulder joint replacement surgeries
  • Patients who are covered by social security
  • Patients who have given informed consent to participate in the study[1]
There are also several conditions that would make a patient ineligible for the study, such as having certain skin conditions, ongoing infections, or allergies to the substances used.[1]

Potential Benefits

The main potential benefit of using this ethanol-based solution is reducing the risk of infection after shoulder surgery. The study aims to determine:

  • How effective the solution is at reducing bacteria on the skin
  • Whether it can help prevent infections for up to 2 years after surgery
  • How it compares to other methods of skin preparation[1]

Precautions and Side Effects

While the study is still ongoing and full results are not yet available, there are some general precautions to be aware of:

  • The solution is for external use only and should not be ingested
  • Patients with known allergies or sensitivities to iodine or alcohol should inform their healthcare provider
  • The study is monitoring for any skin irritation or other adverse reactions to the solution[1]

Aspect Details
Study Focus Reducing Cutibacterium acnes colonization in shoulder surgery
Main Treatment Alcoholic iodine povidone 5% solution containing Ethanol (96 Per Cent)
Additional Treatment 5% benzoyl peroxide applied for 5 days before surgery (in one group)
Target Participants Male patients undergoing shoulder arthroplasty
Follow-up Period 2 years post-surgery
Primary Outcome Number of patients with positive C. acnes samples in the dermis
Secondary Outcomes Bacterial load at various levels, infection rates, strain characterization
Exclusion Criteria Previous shoulder surgery, dermatological conditions, immunosuppression, cancer

FAQ

  • What is the main purpose of using Ethanol (96 Per Cent) in this clinical trial? Ethanol (96 Per Cent) is used as part of an alcoholic iodine povidone solution to prepare the skin before shoulder surgery. Its main purpose is to reduce the bacterial load of Cutibacterium acnes on the skin, which can cause infections after shoulder arthroplasty.
  • Who are the target participants for this clinical trial? The trial targets male patients undergoing shoulder arthroplasty (shoulder joint replacement) for conditions such as primary osteoarthritis, necrosis, massive rotator cuff tear, or old fracture. Participants must not have had previous surgery on the shoulder to be operated on.
  • How long will participants be followed after the surgery? Participants will be followed for 2 years after the shoulder prosthesis implantation to monitor for any Cutibacterium acnes infections.
  • What other treatments are being studied alongside the Ethanol-containing solution? The study also evaluates the effectiveness of applying 5% benzoyl peroxide to the skin incision area for 5 days before the operation. Participants are randomized into two groups: one using Cutacnyl (benzoyl peroxide) and a control group without this additional treatment.
  • What are the main outcomes the researchers are looking for? The main outcomes include the number of patients with positive Cutibacterium acnes samples in the dermis, the average number of positive samples at various levels (skin, fat, and capsular), and the incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after surgery.

Ongoing Clinical Trials on Ethanol (96 Per Cent)

  • Study on Testosterone and Isopropyl Myristate for Women with Turner Syndrome

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Reducing Cutibacterium acnes in Shoulder Surgery for Men Using Benzoyl Peroxide and Ethanol-Povidone Iodine Combination

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Cutibacterium acnes: A type of bacteria that normally lives on the skin and can cause infections, particularly in shoulder surgeries. It was previously known as Propionibacterium acnes.
  • Shoulder arthroplasty: A surgical procedure to replace the shoulder joint with an artificial joint, often used to treat severe arthritis or other shoulder conditions.
  • Benzoyl peroxide: A medication used to treat acne and in this study, applied to the skin before surgery to reduce bacteria.
  • Dermis: The layer of skin beneath the epidermis (outer layer), containing blood vessels, nerve endings, and various glands.
  • Iodine povidone: An antiseptic solution used to clean the skin before surgery, often combined with alcohol for better effectiveness.
  • Bacterial load: The amount of bacteria present in a given sample or area.
  • Phylotypic: Relating to the classification of organisms based on their physical or genetic characteristics.
  • Genotypic: Relating to the genetic makeup of an organism.
  • Osteoarthritis: A type of arthritis caused by wear and tear of the joint cartilage over time.
  • Rotator cuff: A group of muscles and tendons that surround the shoulder joint, providing stability and allowing movement.

References

  1. http://clinicaltrials.eu/trial/study-on-reducing-cutibacterium-acnes-in-shoulder-surgery-for-men-using-benzoyl-peroxide-and-ethanol-povidone-iodine-combination/