Chronic Wound FAQ’s

ExSept Plus Frequently Asked Questions for the Chronic Wound

ExSept Plus is an Electrolytically produced Sodium Hypochlorite Wound Cleanser.

  • 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 (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?  Direct through Angelini Pharma, Inc. or through multiple distributors of podiatric and wound care products.

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.  In addition, the company is ISO certified; ISO 13485 and ISO 9001.

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 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