Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resin Salve Versus Honey Treatment in Wound Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01868412
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Kuopio University Hospital

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.

Condition or disease Intervention/treatment Phase
Wound Healing Wound Infection Device: Abilar 10% resin salve Device: Activon Tube 25 g Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Resin Salve and Medical Honey in Wound Care in Vascular Surgery Patients - A Prospective, Randomized and Controlled Clinical Trial
Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Wound Healing [ Time Frame: 6 months ]
    Healing rate of acute or chronic surgical wound within 6 months after vascular surgery (%).


Secondary Outcome Measures :
  1. Contributors for Wound Healing [ Time Frame: 6 months ]
    Contributors in terms of risk ratio (RR) to delayed wound healing.


Other Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868412


Locations
Layout table for location information
Finland
Kuopio University Hospital
Kuopio, Finland, 70200
Kuopio University Hospital
Kuopio, Finland, FI-70029
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tommi Auvinen, MD Kuopio University Hospital

Layout table for additonal information
Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01868412     History of Changes
Other Study ID Numbers: KUH15101075
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Keywords provided by Kuopio University Hospital:
Wound healing
Wound infection
Resin salve
Medical honey
Additional relevant MeSH terms:
Layout table for MeSH terms
Wound Infection
Wounds and Injuries
Infection