Resin Salve Versus Honey Treatment in Wound Care

Wound Infection Clinical Trial

Official title:

Comparison of Resin Salve and Medical Honey in Wound Care in Vascular Surgery Patients - A Prospective, Randomized and Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868412
• Other study ID #: KUH15101075
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: January 15, 2016
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Research Ethics Commitee of Hospital District of Norther Savo
• Study type: Interventional

Clinical Trial Summary

In recent years, salve prepared from Norway spruce (Picea abies) resin and refined honey from manuka myrtle (Leptospermum scoparium), has successfully been used in medical context to treat both acute and chronic surgical wounds. The objective of this prospective, randomized and controlled clinical trial is to investigate healing rate and healing time of surgical wounds in patients, who have undergone peripheral vascular surgery, and whose complicated wounds are candidate for topical treatment with the resin or honey. In addition, factors contributing with delayed wound healing, antimicrobial properties, safety and cost-effectiveness of the resin salve and medical honey will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Infected of non-infected acute or chronic wound after vascular surgery.

• Need for topical wound care.

• Need for wound healing follow-up at the surgical outpatient department.

Exclusion Criteria:

• Life expectancy less than 6 months.

• Advanced malignant disease.

• Need for extensive surgical wound revision or skin transplantation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Healing
• Wound Infection

Intervention

Device:
• Abilar 10% resin salve
The resin salve may be spread directly onto the wound, after which the area is covered with a bandage suitable for local wound care. The bandage prohibits salve from moving away from the wound area. If the skin condition is more widespread or contains cavities or fistulae, the salve may be spread as a film with a thickness of at least 1 mm onto a gauze or gauze ribbon that is then used to fill the cavity or fistulae channel. Bandages are changed every 1-3 days, depending on the degree of infection and amount of wound secretion.
• Activon Tube 25 g
Wound care with the medical honey is carried out in the same manner than the resin salve treatment: honey may be spread directly onto the wound and the wound area is covered with a bandage suitable for local wound care. Similarly, if the skin condition is more widespread or wound contains cavities or fistulae, the medical honey may be spread as a film with a thickness of at least 1 mm onto a gauze or gauze ribbon that is then used to fill the cavity or fistulae channel. Bandages are changed every 1-3 days, depending on the severity of infection and amount of wound secretion.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other Pre-specified Outcome Measure	Safety and compliance related with the resin salve or medical honey treatment.; Eradication rate of cultured pathogenic bacteria from wounds within 6 months.; Overall costs of resin salve and medical honey treatment within 6 months.	6 months	No
Primary	Wound Healing	Healing rate of acute or chronic surgical wound within 6 months after vascular surgery (%).	6 months	No
Secondary	Contributors for Wound Healing	Contributors in terms of risk ratio (RR) to delayed wound healing.	6 months	No