NCT02482948

MEDIHONEY® Gel Versus Collagenase for Wound Debridement

"Prospective, Randomized, Multi-Center, Efficacy Non-inferiority Study of MEDIHONEY® Gel Versus Collagenase for Wound Debridement"

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue.

Detailed description

BACKGROUND 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.

Conditions

• Ulcer
• Wounds

Interventions

Type	Name	Description
DEVICE	Active Leptospermum Honey (Medihoney)	STudy agent to be applied to the wound daily.
DRUG	Collagenase	Study agent to be applied daily to the wound.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-06-26
• Last updated: 2017-12-02

Locations

1 site across 1 country: United States