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Resin Salve Versus Honey Treatment in Wound Care

Primary Purpose

Wound Healing, Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Abilar 10% resin salve
Activon Tube 25 g
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring Wound healing, Wound infection, Resin salve, Medical honey

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kuopio University Hospital
  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resin & honey

Resin vs. honey

Arm Description

Abilar 10% resin salve

Activon Tube 25 g

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2013
Last Updated
January 15, 2016
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01868412
Brief Title
Resin Salve Versus Honey Treatment in Wound Care
Official Title
Comparison of Resin Salve and Medical Honey in Wound Care in Vascular Surgery Patients - A Prospective, Randomized and Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Wound Infection
Keywords
Wound healing, Wound infection, Resin salve, Medical honey

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resin & honey
Arm Type
Experimental
Arm Description
Abilar 10% resin salve
Arm Title
Resin vs. honey
Arm Type
Active Comparator
Arm Description
Activon Tube 25 g
Intervention Type
Device
Intervention Name(s)
Abilar 10% resin salve
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Activon Tube 25 g
Intervention Description
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 Measure Information:
Title
Wound Healing
Description
Healing rate of acute or chronic surgical wound within 6 months after vascular surgery (%).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Contributors for Wound Healing
Description
Contributors in terms of risk ratio (RR) to delayed wound healing.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Other Pre-specified Outcome Measure
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommi Auvinen, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70200
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
FI-70029
Country
Finland

12. IPD Sharing Statement

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Resin Salve Versus Honey Treatment in Wound Care

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