Resin Salve Versus Honey Treatment in Wound Care

NCT01868412 | Completed

• 1 other identifier: KUH15101075
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Wound Healing; Wound Infection

Keywords

Wound healing; Wound infection; Resin salve; Medical honey

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  Healing rate of acute or chronic surgical wound within 6 months after vascular surgery (%).

  6 months

Secondary Outcomes (1)

• Contributors for Wound Healing

  6 months

Other Outcomes (1)

• Other Pre-specified Outcome Measure

  6 months

Study Arms (2)

Resin & honey

EXPERIMENTAL

Abilar 10% resin salve

Device: Abilar 10% resin salve

Resin vs. honey

ACTIVE COMPARATOR

Activon Tube 25 g

Device: Activon Tube 25 g

Interventions

Abilar 10% resin salve DEVICE

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.

Resin & honey

Activon Tube 25 g DEVICE

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.

Resin vs. honey

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Life expectancy less than 6 months.
• Advanced malignant disease.
• Need for extensive surgical wound revision or skin transplantation.

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (2)

Kuopio University Hospital

Kuopio, Kuopio, 70200, Finland

Location

Kuopio University Hospital

Kuopio, Kuopio, FI-70029, Finland

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Tommi Auvinen, MD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

FI (2)