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OpenTrials
Completed

NCT Number: NCT01868412

Resin Salve Versus Honey Treatment in Wound Care

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital, Kuopio, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Wound Healing

    Time frame: 6 months

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

Secondary outcomes

  1. Contributors for Wound Healing

    Time frame: 6 months

    Contributors in terms of risk ratio (RR) to delayed wound healing.

Other outcomes

  1. Other Pre-specified Outcome Measure

    Time frame: 6 months

    • 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.

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2013
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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