Resin Salve Versus Honey Treatment in Wound Care

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Infection; Wound Healing
• Intervention / Treatment: Device: Abilar 10% resin salve; Device: Activon Tube 25 g

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70200
    • Kuopio University Hospital
  • Kuopio, Finland, FI-70029
    • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resin & honey; Abilar 10% resin salve	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.
Active Comparator: Resin vs. honey; Activon Tube 25 g	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing	Healing rate of acute or chronic surgical wound within 6 months after vascular surgery (%).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contributors for Wound Healing	Contributors in terms of risk ratio (RR) to delayed wound healing.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Investigators: Principal Investigator: Tommi Auvinen, MD, Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: January 15, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Wound healing; Wound infection; Resin salve; Medical honey
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: KUH15101075