MEDIHONEY® Gel Versus Collagenase for Wound Debridement
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|ClinicalTrials.gov Identifier: NCT02482948|
Recruitment Status : Terminated (Poor enrollment.)
First Posted : June 26, 2015
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment|
|Ulcer Wounds||Device: Active Leptospermum Honey (Medihoney) Drug: Collagenase|
An important aspect of wound bed preparation for healing or grafting is the recognition that wounds often have underlying pathogenic abnormalities that cause necrotic tissue to accumulate. Therefore, in order to facilitate wound progression, repeated removal of necrotic tissue may be necessary as long as the wound is chronic. Debridement is defined as the removal of nonviable material, foreign bodies, and poorly healing tissue from a wound. Although surgeons recognize the importance of debridement, few data have been generated in randomized trials to support its use. Traditionally, debridement has been undertaken as a single therapeutic step within defined time frames. The most direct form of debridement is surgical excision. Although this may be applicable for acute wounds, it is unlikely to remove the necrotic burden that may continually accumulate in a chronic wound. Although there are other forms of debridement including enzymatic and biologic; in the case of non-healing wounds, the form of debridement with the most compelling evidence of healing efficacy is autolytic debridement , Therefore, for patients who are poor candidates for surgical debridement or have limited access to a surgeon, autolytic debridement may be considered an effective form of continuous debridement.
2.1 Primary Objective
The primary objective of this study is to evaluate the non-inferiority of MEDIHONEY® Gel (Active Leptospermum Honey-ALH Gel) compared to (Santyl) Collagenase, two FDA cleared/approved treatments, with respect to the percent reduction of necrotic (including slough and eschar) tissue in the wound at the end of 14 days +/- 2 days.
2.2 Secondary Objective
The secondary objective of this study is to compare the two treatment groups with respect to the percent reduction from randomization for necrotic tissue (including slough and eschar) at weeks 1, 3 and 4 +/- 2 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||"Prospective, Randomized, Multi-Center, Efficacy Non-inferiority Study of MEDIHONEY® Gel Versus Collagenase for Wound Debridement"|
|Study Start Date :||June 2015|
|Primary Completion Date :||March 2017|
|Study Completion Date :||March 2017|
Active Comparator: Collagenase
This is an enzymatic debridement agent to remove non-viable tissue from wounds to be applied daily
Study agent to be applied daily to the wound.
Other Name: Santyl
Active Comparator: Active leptospermum honey
This is an active medicinal grade honey used to promote autolytic debridement and applied daily
Device: Active Leptospermum Honey (Medihoney)
STudy agent to be applied to the wound daily.
Other Name: Medihoney
- Necrotic tissue reduction [ Time Frame: two weeks ]Necrotic tissue percent reduction in the wound at the end of 14 days
- Percent wound reduction [ Time Frame: 4 weeks ]Percent wound reduction from randomization at weeks 1, 3 and 4.
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): NCT02482948
|United States, Florida|
|Innovative Healing Systems|
|Tampa, Florida, United States, 33614|
|Principal Investigator:||Ravi Patel, MD||Innovative Healing Systems|