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About Gelclair

About Gelclair®

How does
Gelclair® work?

Gelclair® is a viscous gel specially formulated to aid in the management of lesions of the oral mucosa. It forms a protective film that, by adhering to the mucosa of the oropharyngeal cavity, offers rapid and effective pain management.1 It is presented as a concentrated gel in sachets for dilution with water.

  • Gelclair® contains PVP (polyvinylpyrrolidone) and sodium hyaluronate in a gel.
  • When applied around the mouth, forms a protective coating that adheres to the lining of the mouth.
  • The bioprotective coating offers rapid and effective pain management.1-3
  • Pain is significantly reduced following the first use of Gelclair®.1
  • Gelclair® can potentially improve the ability to eat and drink4 and, unlike preparations with an alcohol or anaesthetic base, does not sting on application.1,5-9

Intended use

Gelclair® helps in the management of painful symptoms associated with Oral Mucositis, such as lesions of the Oropharangeal cavity. Gelclair® forms a protective film that helps to provide pain relief, soothing mouth lesions including those caused by medication, disease, radiotherapy, chemotherapy, oral surgery, traumatic ulcers caused by dental braces and dentures, and ageing.

Mode of action video

Play
Help take away the pain of oral mucositis

How to use Gelclair®

Frequency of use

3 times daily

Or as needed

30 - 60 Minutes

Before eating or drinking

Instructions for use

Tear along top of the sachet.

Squeeze the Gelclair® into a glass.

Add about 3 tablespoons of water (40ml) and stir well.

Use as a mouthwash straight away - rinsing around the mouth for at least 1 minute, or for as long as possible to coat the tongue and inside of the mouth completely.

Gargle and spit out.

For patients that are not able to rinse and gargle, Gelclair® can be used undiluted - applied directly with a sponge or swab.

Throw away any unused Gelclair® mouthwash.

Clinical Evidence

Study One

Gelclair®: potentially an efficacious treatment for chemotherapy-induced mucositis

De Cordi D, Martina S.

Presented at the Third Italian Anti-Tumour League Congress for Professional Oncology Nurses, Conegliano, Italy, 10-12 October 2001.

Study Outline

Thirty patients with chemotherapy-induced oral mucositis were evaluated for pain, functionality (ability to eat and drink) and grade of oral mucositis, at baseline, 1 day and 3 days after taking Gelclair®

Results

  • Pain: 83% reported a reduction in pain, 13% remained the same and 3% showed initial improvement but then got worse.
  • Ability to eat and drink: 83% showed distinct improvement, 7% remained the same, 7% got worse, while 3% considerable improvement followed by slight worsening.
  • Grade of mucositis: 57% improved, 40% remained the same, 3% got worse.

Patients' Response

Study Two

Efficacy of Gelclair® in reducing pain in patients with oral lesions − preliminary findings from an open pilot study

Innocenti M, Moscatelli G, Lopez S.

Pain Symptom Manage 2002; 24(5): 456−457.

Study Outline

Thirty patients with painful lesions of the mouth and oropharynx (caused by various diseases) were evaluated for short term (5−7 hours) and medium term (7−10 days) effects of Gelclair® on the severity of pain on swallowing and eating.

Results

The significant reduction was observed with the short term not medium term. The results are encouraging but not conclusive. In this 10 day trial, results indicated that Gelclair® rapidly and effectively reduces pain associated with oral lesions (e.g. oral mucositis), and can improve ability to eat and drink, with continued use.

Patients' Response

Study Three

A preliminary study of Orassist (Gelclair®) in the management of oral mucositis

Berndtson M.

Svensk Sjukhustandlakartidning {Swedish Hospital Dentistry} 2001; 26(3): 17–21.

Study Outline

Ten patients were given Gelclair® to evaluate its effect on their symptoms of oral mucositis.

Results

All reported that the product was acceptable for its taste and consistency, and a palliative soothing effect was noted.

Study Four

An audit of the efficacy of Gelclair® for mouth pain in patients undergoing radiotherapy or chemotherapy

McLean M.

Poster presented at the British Association of Head and Neck Oncology Nurses National Study Day on Sharing Good Practice in Head and Neck Cancer Nursing, 12 June 2009.

Study Outline

Twenty−six patients with Grade 2 oral mucositis were given Gelclair® to evaluate its effect on reducing the pain of oral mucositis, increasing functionality and reducing the need for concomitant analgesic consumption. Results were obtained for 16 patients who completed the full 7−day study.

Patients were treated for 7 consecutive days with Gelclair, 1 application 3 times a day, between meals. Evaluations were carried out at a first review assessment with a second follow up review 3–7 days later, considering the following parameters:

  • Patients were asked to score their pain according to a scale where 0 = no pain, to 10 = worst pain imaginable (unbearable).
  • Patients were asked to score their ability to eat and drink comfortably according to a 6-point scale, where a reduction in functionality reflects an improvement in comfortable eating.
  • Necessary dosage of concomitant analgesics.

Results

  • Pain: by the end of day 3, the average pain score had reduced from 6.6 before treatment to 4.2, a reduction of 36% (p=0.0021).
  • Pain: by the end of day 7, the average pain score had decreased from 6.6 to 2.4, a decrease of 4.2 points, signifying an average pain score reduction of 63% at the end of the 7−day assessment period (p<0.0001).
  • Analgesic consumption: by the end of day 3, the average number of analgesic doses taken by patients had reduced from 4.2 to 2.3, an average reduction of 46% (p=ns). By the end of day 7, the average number of analgesic doses had reduced to 2.4, an average reduction of 43% (p=ns).
  • Functionality: Gelclair® treatment enabled a more comfortable intake of food and fluids by the end of day 7, functionality scores were reduced by an average of 17% (p=ns).

Patients' Response