Proof of Efficacy and Key Performance Attributes

When evaluating the efficacy of the BeneHold™ Post-Op Dressing with CHG, in addition to establishing the antimicrobial effectiveness of CHG itself, a number of other important factors need to be considered and validated to ensure its clinical utility as an antimicrobial dressing. Let’s review each of them here.

Antimicrobial Efficacy

Antimicrobial-Resistant Pathogens Associated With Healthcare-Associated Infections¹

BeneHold™ Post-Op Dressing with CHG was exposed to 10 microorganisms commonly associated with surgical site infections. The test involved incubating the dressing while in contact with a known inoculum for seven days, then counting the number of surviving microorganisms relative to the population remaining on a non-antimicrobial placebo dressing. To be considered antimicrobial, a minimum 4-log reduction in microbial count must have been observed against bacteria and yeast. No surviving microorganisms were recovered after seven days’ contact with the BeneHold™ Post-Op Dressing with CHG, demonstrating it to be effective against all ten microorganisms, including Carbapenem-Resistant Enterobacteriaceae (CRE), per the >4-log reduction criteria.*

_{*4-log reduction on yeast at initial time point}

^{_{**Results based on the average of 3 batches; tests performed by an independent laboratory.

***Results based on one batch; tests performed in triplicate by an independent laboratory}}

Antimicrobial Efficacy: In Vivo Surgical Wound Model²

Since the effectiveness of postoperative antimicrobial dressings in reducing surgical site infections is relatively unknown, especially regarding the efficacy of chlorhexidine gluconate (CHG) impregnated into postoperative dressings, a pilot study was conducted to examine the efficacy of the BeneHold™ CHG Post Operative dressing at reducing the burden of methicillin-resistant Staphylococcus aureus (MRSA) in an in vivo porcine, incisional-wound model.

The study involved 3 different wound dressings - standard gauze, transparent placebo dressing and BeneHold™ CHG Post Op Dressing. Five young female swine were prepped for surgery, ensuring a clean and smooth skin surface. Eight full thickness linear incisions were made on each animal, and the wounds were closed using 3 simple sutures. Each suture was challenged with a MRSA inoculation suspension that was then spread over the incision site to a 0.5 cm wide margin. The inoculum was allowed to air dry and then a post-operative dressing was applied. Each sutured incision area was dressed randomly with 1 of the 3 wound dressings.

The dressings were left in place undisturbed for 72 hours. Tissue samplings were harvested from each wound, including the incision and 2-3 mm of surrounding skin tissue along with the intact dressing.

The table below outlines the results of the study. After 3 days there was no recovery of any surviving colony-forming units of MRSA in any of the 8 wounds treated with the BeneHold CHG Post Op dressing. The average microbial recovery from the wounds treated with the Placebo and Standard Gauze Dressing was 4.2 log₁₀ cfu/g and 3.2 log₁₀ cfu/g respectively.

In this pilot study, BeneHold™ CHG Post Op dressing was effective in significantly reducing the burden of MRSA for 3 days when compared to a placebo and the standard of care gauze dressings.

Click on the link below to read the full article.
Preliminary analysis of the antimicrobial activity of a postoperative wound dressing containing chlorhexidine gluconate against methicillin-resistant Staphylococcus aureus in an in vivo porcine incisional wound model

Fluid Management

Wound dressings can play an important role in maintaining the optimal conditions for moist wound healing. There are two main mechanisms by which BeneHold™ Post-Op Dressing with CHG manages moisture:

Static Absorption: The dressing soaks up moisture and exudates into the absorbent adhesive layer. This static absorption quantifies how much fluid can be absorbed.

Breathability: Moisture can also pass through the dressing and escape through the waterproof barrier film in the form of water vapor. The moisture vapor transmission rate (MVTR) quantifies the speed of escape.

The sum of the MVTR and static absorption represents the dressing’s total fluid handling capacity.

In a fluid handling capacity test, BeneHold™ Post-Op Dressing with CHG was found to have an MVTR comparable to traditional transparent film dressing. However, in comparison to the traditional transparent film dressing, BeneHold™ Post-Op Dressing with CHG demonstrated a static absorption capacity more than four times that of the standard transparent film dressing.¹

The study concluded that the unique combination of fluid absorption and breathability allows BeneHold™ Post-Op Dressing with CHG to manage light to moderate levels of exudate, enabling a moist wound environment conducive to wound healing.

Proven Safety

BeneHold™ Post-Op Dressing with CHG, while demonstrating solid in vitro antimicrobial efficacy, was found to be non-cytotoxic, non-irritating and non-sensitizing in contact with the skin.¹

An irritation study, in which the dressing was applied to healthy human volunteers’ lower abdomen or back for 7 days or until the dressing fell off, concluded BeneHold™ Post-Op Dressing with CHG was non-irritating to healthy human skin and did not potentiate any skin irritation or cause any damage to the skin.¹

LEARN MORE

Download Our BeneHold™ Post-Op Dressing with CHG Technology Bulletin

Read Our Latest Article On The antimicrobial efficacy against MRSA in an vivo surgical incisional wound model

Custom Solutions and Future opportunities

BeneHold CHG antimicrobial adhesive technology can be customized to meet the needs of a wide range of applications and performance requirements.

If you are searching for an adhesive solution that offers the additional benefit of an antimicrobial agent, or would like more information on how you can take advantage of this unique BeneHold™ CHG adhesive technology, contact Avery Dennison Medical by completing the form below and a member of our team will contact you shortly.

CHG is incorporated directly into the adhesive

Option to tailor onset and duration of antimicrobial activity

Ability to tailor the adhesive thickness, adhesion level and fluid management

Connect with us and uncover how BeneHold CHG can advance your product portfolio

We exclusively license the technology for specific applications and territories
Opportunity to bring innovation where infection prevention is of strategic focus
Currently expanding into Surgical and Advanced Wound Care markets
Open to reviewing opportunities in other areas adjacent with the right partnership opportunity

Precautions

BeneHold™ Post-Op Dressing with CHG should not be placed over infected wounds. This device is not intended to treat Surgical Site Infections (SSIs) or other percutaneous device-related infections. This device has not been studied in a randomized clinical study to determine its effectiveness in preventing such infections.

Active bleeding at wound sites should be stabilized before applying the dressing.

Do not stretch the dressing before applying it to the skin. Dressings applied under tension can cause trauma to the skin.

To ensure good adhesion and to help prevent skin irritation, remove detergent residues and allow all skin preparations and protectants to dry completely before applying the dressing to the skin.

Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner.

For proper use, clinicians should be trained in the use of this device.

Warnings

BeneHold™ Post-Op Dressing with CHG should not be used as a replacement for sutures and other primary wound closure methods.

BeneHold™ Post-Op Dressing with CHG should not be used on third-degree burns.
Do not use BeneHold™ Post-Op Dressing with CHG on premature infants or infants younger than 2 months of age. Use of this product on premature infants may result in hypersensitivity reactions or necrosis of the skin.
BeneHold™ Post-Op Dressing with CHG should not be used as a primary means to fix arterial catheters or arterial cannulae.
For external use only. Do not allow contact of the BeneHold™ Post-Op Dressing with CHG with ears, eyes, mouth or mucous membranes.
Do not use the BeneHold™ Post-Op Dressing with CHG on patients with a known hypersensitivity to CHG. Adverse reactions such as irritations, sensitization and generalized allergic reactions have been reported with the use of CHG.
If allergic reactions occur, discontinue use of the BeneHold™ Post-Op Dressing with CHG immediately and, if severe, contact a physician.
Stop using the BeneHold™ Post-Op Dressing with CHG if the patient experiences symptoms such as: wheezing or difficulty breathing, swelling face, hives that can quickly progress to more serious symptoms, severe rash or shock (which is a life-threatening condition that occurs when the body is not getting enough blood flow). These symptoms are associated with an allergic reaction to CHG.
Patients must be questioned about any prior allergic reactions to a medical device containing CHG. Alternatives must be considered under such circumstances.
Literature searches found hypersensitivity reactions associated with the topical use of CHG have been reported in several countries. Caution should be used when using chlorhexidine-containing preparations, and the patient should be observed for the possibility of hypersensitivity reactions.

Do not use on immune-compromised patients or patients with underlying skin pathology which compromises the epidermal barrier. Use of this product may result in erosive contact dermatitis.
Do not use BeneHold Post-Op Dressing with CHG over surface based adhesive wound closures.
Intended for single patient use only.
Do not reuse. As with all adhesive-based products, adhesive effectiveness and functionality can decline after the first use and the product will not perform as specified. Reuse may lead to infection or other illness or injury.
Store dressing in a cool, dry place. Keep away from direct sunlight. Do not store above 25°C/77°F. Do not use if packaging is damaged.

References:
1. Avery Dennison Medical Data on File.
2. Mana, TSC, Donskey C, Carty, N, Perry, L, Leaper, D, Edmiston, CE. Preliminary analysis of the antimicrobial activity of a postoperative wound dressing containing chlorhexidine gluconate against methicillin-resistant Staphylococcus aureus in an in vivo porcine incisional wound model. Am J Infect Control. 2019; 47: 1048-1052.