Treatment of pressure sore or bed sore with GANIKDERMA® products

A pressure sore (pressure ulcer) is a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in conjunction with shear and/or friction. Many areas of the body, especially the sacrum and the heel, are prone to the development of pressure ulcers.

People with impaired mobility (e.g. stroke or spinal cord injury patients) are most vulnerable to pressure ulcers. Other factors that predispose people to pressure ulcer formation are poor nutrition, poor sensation, urinary and fecal incontinence, and poor overall physical and mental health.

Areas prone to development of pressure ulcers:

Area of Body Underlying Bony Prominence Comments
Base of buttocks Ischium Tends to occur in patients confined to wheelchair and in seated
position for much of the time
Upper outer thigh Greater trochanter Tends to occur in patients who spend prolonged periods in bed
Heel of foot Calcaneus May occur in both of above patient populations
Back of head Occiput of skull Tends to occur in patients who spend prolonged periods in bed
Lower back Sacrum Tends to occur in patients who spend prolonged periods in bed

Classification of Pressure Sores

There are different systems for classifying a pressure sores based on their severity, taking into consideration the surface area and depth of the ulcer, the tissues affected, and presence or absence of necrosis, exudate, and slough.

The most commonly used system is the North American National Pressure Ulcer Advisory Panel system and the European Pressure Ulcer Advisory Panel System.

Characteristics of the stages are summarized below.

Stage I: usually refers to a change in the skin without breakage.

Stage II: refers to a shallow ulcer with partial thickness skin loss.

Stages III and IV: are considered advanced ulcers with full thickness skin loss affecting tissues beneath the dermis.

A new category was recently added to represent damage of underlying soft tissues while the skin remained intact.


Treatment of pressure sores

Pressure sores are extremely difficult to heal. Once they develop, this type of chronic wound is very resistant to any known medical therapy. Estimation of complete healing for pressure sores are as low as 10%. As few as 13% of pressure ulcers (sores) heal by 2 weeks in acute hospital settings. In long-term care, the rate of healing depends on the initial stage of the pressure sore.

Healing rates for stage III pressure ulcers may be as high as 59% in 6 months, but other patients require treatment duration of up to 1 year. Only one third of stage IV pressure ulcers heal after 6 months of therapy, but one half of patients admitted with pressure ulcers die during this time period. Thus, prevention offers the best opportunity for management.

Several treatment variables were identified to be significant associated with improved healing of pressure ulcer healing:

  • Moist dressing (in Stage II and Stage III/IV ulcers)
  • Receiving sufficient enteral feeding (>30 kcal/kg)
  • Use of exudate management dressing
  • Rehabilitation services

Once an ulcer appears, additional treatment options can include:

  • Local ulcer care, including maintaining proper moisture balance and use of antibacterial dressings
  • Debridement (removing dead tissue)
  • Keeping unaffected tissue around the pressure ulcer clean and lightly moisturized
  • Surgical intervention to provide muscle flaps and skin grafts for some patients

Treatment of pressure sores with GANIKDERMA® products

GANIKDERMA® Ointment or Impregnated Dressings avoids wound contamination with urine or fecal, if primary dressing is covered with a secondary dressing made of semipermeable polyurethane film or a semipermeable adhesive dressing. Even wound contamination occurs, due to bacteriostatic, limited bactericidie and antifungal properties, adverse effects are minimal.

Temporary use of a Foley catheter (or intermittent catheterization) should be considered. A diverting colostomy should be considered if persistent fecal contamination is a problem.

If the wound contains foul-smelling, necrotic tissue: Autolytic debridement achieved with GANIKDERMA® Ointment by using occlusive dressings maintains wound fluid in contact with the necrotic tissue. Autolysis itself uses the body’s own enzymes (MMPs), and moisture to re-hydrate. In addition, the ointment is rich in provitamin A that ensures hydration of tissues.

/According to Clinical Investigation (EN ISO 14155):

The total area of the pressure sores treated using GANIKDERMA® products was reduced by half after 16 days of treatment; during the healing process there were no adverse effects caused by the use of GANIKDERMA® products.

Following 38.5 days of treatment, the mean area of the pressure sores was 25% of the initial one; following 81 days of treatment, 83% of the pressure wounds healed completely; the other 17% had an area of 0.85% of the initial one (considered as 100%).

After 14.5 days of therapy with GANIKDERMA® products, the total volume of the pressure sores was reduced by 50%, and after 14.5 days – by 25%. Following 69 days of treatment the depth of the pressure sores was negligible, the mean volume becoming zero.

During the treatment using GANIKDERMA® products no infection or foul odor were registered; the colorimetric assessment of the wound tissue (black – necrosis, black/brown dried/humid, yellow – fibrin, red – granulation tissue, pink – epithelium) during the healing process stands for the efficiency of GANIKDERMA® products in the treatment of the chronic wounds: in all the cases the black/yellow tissue turn in red/pink tissue due to the products’ fast and efficient debridement value, with no necrosis recurrence. The necrotic tissue was chemically debrided following 10 days (mean value), fastening the healing process.

On the Wong-Baker scale, the mean value of pain level during GANIKDERMA® products dressing removal was 0.89 (imperceptible pain).

Those data assess the efficiency of the use of the GANIKDERMA® products in the management of patients with multiple pressure sores.

The dressing using GANIKDERMA® products were changed at 1,41 days (mean value); the health professionals mentioned the easiness of dressing appliance/removal, with no harm to the granulation/new epithelization tissue.

The new epithelium covering the healed pressure wound was of very good quality – stable and aesthetically pleasing, with no pathologic scar formation.


Clinical cases cured with GANIKDERMA®

Patient 1 Bed sore

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Patient 2 Bed Sore

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Patient 3 Bed Sore

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Patient 4 Bed Sore

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