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1 Primary Wound Dressing®: clinical experience

Severin Läuchli
University Hospital Zurich, Switzerland and
President Swiss Association for Wound Care (SAfW)
In 2011, a novel natural primary wound dressing (1 Primary Wound Dressing®; Phytoceuticals) based on Neem oil and St John’s Wort oil was introduced to the Swiss wound care market.
In India, the Neem tree is one of the most important plants used in traditional medicine and is sometimes referred to as ‘Sacred Tree’ because all parts of the plant are used for the treatment of a variety of diseases. St John’s Wort plays a central role in Western traditional medicine and is widely known as a herbal treatment for depression (a different extract of the plant is used in the 1 Primary Wound Dressing®). This novel, innovative product has received a CE Mark in the European Union.
Mode of action
The wound healing effects are brought about by the oil film that is created on the wound and the surrounding skin and the fatty acids present in the oil. The product: 
  • exerts an antimicrobial effect
  • protects the skin and supports a healthy skin barrier function and
  • enables a balanced moist environment obtained by the semi-occlusive layer the oil layer creates. 
Cell proliferation is activated and, despite the moist environment, bacterial load remains under control because of the antimicrobial effect. In addition the oil layer prevents the secondary dressing from adhering to the wound, thereby preventing damage to the granulation tissue during dressing changes, which leads to improved epithelisation and reduced pain. 
Clinical experience
Clinicians and wound experts from a number of Swiss hospitals generated 105 case reports from patients who had been treated with the novel wound therapeutic (Tables 1 and 2). The 105 cases are divided into 37 acute and 68 chronic wounds with an average patient age of 70 years (female: 51 years; male: 54 years; standard deviation ±16). The patients had the typical concomitant diseases associated with their age and primary diagnoses. Table 3 summarises the important parameters for the three most prevalent types of wound in the case studies.
Results 
Treatment duration and wound closure
  • 
The average previous treatment duration was five months
  • The average treatment duration with 1 Primary Wound Dressing® was two months 
  • The treatment with 1 Primary Wound Dressing® led to wound closure in 63 of 105 patients (acute: 31, chronic: 32). By the time of the evaluation, the treatment of nine cases was still ongoing. The treatment did not result in wound closure in 24 cases over a treatment period of up to 12 weeks. The treatment was stopped in seven cases because of different reasons (pain, surgical intervention, possible allergic reaction). Two patients died during the course of treatment (no connection to therapy).
Granulation
  • 
The wound care specialists carrying out the evaluations noted that in 57 of 105 cases (54%) the granulation phase was induced faster than what they would have expected from their clinical experience. Granulation was induced fastest in postsurgical wounds (64%) and decubitus (89%).
  • 
Of particular note is a series of nine scalp wounds with exposed bone following skin tumour excision. Treating this type of wound is very challenging because they have no, or only very slow formation of, granulation tissue and are often impossible to heal by secondary intention. The Department of Dermatology of the University Hospital Zurich successfully treated scalp wounds with exposed bone in nine patients after tumour excision with 1 Primary Wound Dressing® (see Box 1). The results confirm the positive effect 1 Primary Wound Dressing® has on the induction of granulation tissue.
Maceration of the periwound skin
  • 
At treatment start the periwound skin of 12.3% (13/105) of wounds were macerated
  • 
After 50% of treatment the periwound skin of 4% (4/105) of all wounds were macerated; this equates to a reduction of 70%
  • 
A total of 90 wounds did not macerate during the treatment.
Fibrin
  • 
The removal of fibrin slough from the wound bed is a serious challenge because it can be a painful experience for the patient or it can delay wound healing because granulation tissue might be damaged. The application of 1 Primary Wound Dressing® may positively support the removal of fibrin slough. This was tested in three cases (ulcus cruris) where a reduction of fibrin slough of 80% was observed within the first three days of treatment. 1 Primary Wound Dressing® was applied daily and no additional debridement methods were performed.
Adherence of the secondary dressing
  • 
In 96 cases dressing changes were carried out without complications. In 7 of 105 cases the secondary dressing did adhere to the wound. The reasons for adhering were a smaller amount of 1 Primary Wound Dressing® applied and longer intervals between dressing changes than recommended by the manufacturer. Data were absent for two cases.
Adverse reactions
No serious adverse reactions associated with 1 Primary Wound Dressing® were observed in 102 cases (98%). An allergic reaction to 1 Primary Wound Dressing® was reported in three. All the patients reporting an allergic reaction suffered from multiple allergies.
Pain reduction
Table 4 summarises the observed pain reductions experienced with 1 Primary Wound Dressing®.
Conclusions
Results from extensive case studies in different types of acute and chronic wounds suggest that 1 Primary Wound Dressing® can be used as an effective primary wound dressing that promotes wound healing and protects the periwound skin. 
1 Primary Wound Dressing® leads to an impressive induction of granulation tissue, even in very deep wounds. It proved to be simple to use and increases patient comfort greatly. 

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