Resin Salve Versus Honey Treatment in Wound Care
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|ClinicalTrials.gov Identifier: NCT01868412|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : January 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Wound Healing Wound Infection||Device: Abilar 10% resin salve Device: Activon Tube 25 g||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Wound Healing [ Time Frame: 6 months ]Healing rate of acute or chronic surgical wound within 6 months after vascular surgery (%).
- Contributors for Wound Healing [ Time Frame: 6 months ]Contributors in terms of risk ratio (RR) to delayed wound healing.
- 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.
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
|Kuopio University Hospital|
|Kuopio, Finland, 70200|
|Kuopio University Hospital|
|Kuopio, Finland, FI-70029|
|Principal Investigator:||Tommi Auvinen, MD||Kuopio University Hospital|