Resin Salve Versus Honey Treatment in Wound Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Healing, Wound Infection

Intervention / Treatment
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* Device: Abilar 10% resin salve
* Device: Activon Tube 25 g


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resin & honey<br>Abilar 10% resin salve | Device: Abilar 10% resin salve<br>* 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.<br>|
| Active Comparator: Resin vs. honey<br>Activon Tube 25 g | Device: Activon Tube 25 g<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound healing, Wound infection, Resin salve, Medical honey