FAQs: People Want to Know
EXSEPT PLUS® Frequently Asked Questions for the Chronic Wound
EXSEPT PLUS® is an Electrolytically-Produced Sodium Hypochlorite Wound Cleanser. Angelini Pharma cannot sell directly to patients but only to doctors, healthcare facilities and distributors.
| Active Ingredient: | Sodium Hypochlorite (NaOCL) 0.114% |
| Inert Ingredients: | Sodium Chloride (NaCL) 1.7%, Purified Water (H20) |
1. What is a Wound Cleanser? A tissue-friendly cleanser for chronic non-healing wounds when applied directly to the wound will assist in the cleansing of the wound and removing dead necrotic tissue.
2. Why should I use EXSEPT PLUS®? EXSEPT PLUS® has been tested to effectively cleanse the wound prior to debridement.
3. Can EXSEPT PLUS® be contaminated? No, EXSEPT PLUS® is a skin cleanser with sodium hypochlorite, an anti-microbial preservative. EXSEPT PLUS® has been shown to be effective against the following organisms, thereby minimizing the risk of contamination:
Microbiologic Efficacy Table for EXSEPT PLUS® (0.055% HOCl): Percent Kill Viable CFUs
Reduction | Time (min)* | |
| Staphylococcus aureus | 100% | 1 |
| Streptococcus faecalis | 100% | 1 |
| MRSA | 100% | 5 |
| VRE | 100% | 5 |
| Enterococcus hirae | 100% | 5 |
| Micrococcus luteus | 100% | 1 |
| Escherichia coli | 100% | 1 |
| Klebsiella pneumonia | 100% | 1 |
| Proteus vulgaris | 100% | 1 |
| Pseudomonas aeruginosa | 100% | 1 |
| Mycobacterium smegmatis | 100% | 1 |
| Serratia marcescens | 100% | 3 |
| Salmonella cholerausuis | 100% | 15 |
| Microsporum gypseum | 100% | 1 |
| Candida albicans | 100% | 3 |
| Aspergillus niger | 100% | 5 |
| Trichophyton mentagrophytes | 100% | 5 |
| Herpes simplex virus | 100% | 15 |
| Poliovirus | 100% | 15 |
| HIV-1 | >99.999% | 1 |
| Hep A | 100% | 0.5 |
| Hep B | 100% | 0.5 |
| Hep C (0.0008% HOCl) | 100%** | 15 |
*Time refers to exposure time of specific test. 100% elimination may occur faster. **100% Inhibition
4. Will EXSEPT PLUS® burn or irritate the wound site? No, it is non-cytotoxic, non-irritating and gentle to the wound site. In order to reduce the incidence of maceration of the surrounding tissue, EXSEPT PLUS® should only be used in the wound bed.
5. How do I use EXSEPT PLUS® on a wound site? Uncap the EXSEPT PLUS® and pour over and into the wound site covering all areas of the wound. It is recommended to leave the cleanser in place for two minutes before removing the cleanser with multiple gauze pads. If additional pressure is needed to cleanse the wound a 35ml syringe with a 19 gauge needle will deliver approximately 8 PSI to the wound site. (The use of a skin protectant is recommended to reduce the incidence of skin maceration.)
EXSEPT PLUS® can also be used as a daily cleanser for home use. Open gauze pads and saturate with 8 – 12ml of the cleanser, apply the gauze pads to the wound site. (Do not overlap the gauze onto the surrounding healthy tissue.) Starting at the center of the wound, wipe the wound in a circular motion working toward the edge of the wound.
6. How does EXSEPT PLUS® compare to Dakins Solution? EXSEPT PLUS® is electrolytically produced Sodium Hypochlorite (better purity), active ingredient 0.114% Sodium Hypochlorite. Dakin’s Solution at full strength is 0.50% at half-strength 0.25%; or roughly twice the NaOCL (may be irritating to the skin) concentration of EXSEPT PLUS®. EXSEPT PLUS® has a lower sodium hypochlorite concentration but is more effective on cleaning the wound of bioburden compared to Dakin’s because of the lower pH (a higher pH results in decreased formation of hypochlorous acid, and thus lower germicidal efficacy).
7. What is the pH level of EXSEPT PLUS®? 9 – 10.5
8. What is the expiration period once a bottle is opened? EXSEPT PLUS® is stable for 6 months after opening and has a 30 month shelf life from the date of manufacture.
9. How can I purchase EXSEPT PLUS®? Directly through Angelini Pharma Inc or through multiple distributors of podiatric and wound care products. Angelini Pharma can’t sell directly to patients but only to doctors, healthcare facilities and distributors.
10. What is the intended use for EXSEPT PLUS®? Debriding and moistening chronic wounds including: Diabetic Ulcers; Venous Stasis Ulcers; Pressure Ulcers and Post-surgical wounds.
11. Is EXSEPT PLUS® registered with the FDA? EXSEPT PLUS® is cleared with the FDA and Angelini Pharma is registered with the FDA. Angelini Pharma follows all applicable rules and regulations for the production and delivery of all products under the Angelini Pharma name.
12. Does EXSEPT PLUS® utilize any materials or components that contain certain known toxic substances? Angelini Pharma does not utilize (directly or indirectly) the following substances as ingredients or additives or processing aids or packaging components in items it manufactures and/or distributes in the United States: DEHP or any other related phthalates; natural rubber latex or derivates; PVC or Bisphenol A.
13. Where can I get additional information? www.angelini-us.com