Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446823
Status:
COMPLETED
Last Update Posted:
2007-03-13
First Post:
2007-03-09
Brief Title:
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
Sponsor:
Xylos Corporation
Organization:
Xylos Corporation
Study Overview
Official Title:
A Prospective Randomized Controlled Clinical Study to Evaluate the Effectiveness of a Cellulose Matrix Wound Dressing for Autolytic Debridement and Healing of Chronic Venous Ulcers
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XCell
Brief Summary:
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally autolytically remove nonviable tissue and create a healthy vascular wound bed Results will compare venous ulcers treated with Xylos XCell cellulose dressing plus standard care to those treated with standard care alone The hypothesis is that XCell will demonstrate more autolytic debridement than the standard of care
Detailed Description:
Chronic wounds are a problem for both the patient and the health care provider The definition of a chronic wound is one that deviates from the expected sequence of repair in time appearance and response to aggressive treatment These wounds can be separated into distinct classes by etiology specifically pressure ischemic venous neuropathic diabetic inflammatory or infective wounds The degree of severity can be quite diverse spanning the range of superficial epidermal injury to full-thickness skin loss with extensive destruction tissue necrosis and damage to supporting structures including muscle tendon and or bone Treatment of chronic wounds should begin with the management of the underlying etiology For example In pressure ulcers the elimination or reduction of pressure is the primary goal In venous ulcers improving venous insufficiency or reducing venous hypertension should come first and in diabetic foot ulceration proper off loading is essential After treatment of the underlying pathology one thing that all chronic wounds have in common is that they require wound bed preparation in order to stimulate the healing process
Most clinical wound care trials to evaluate therapeutic agents for wounds have been designed to measure healing as the primary endpoint The sequence of events begins with patient examination wound classification and then the application of the test agent In most cases the test agent is placed over a wound that is contaminated with excessive bacteria needs debridement or requires wound bed preparation such as exudate control
A new wound dressing Xylos XCell cellulose wound dressing is a unique biosynthetic matrix material that is hydrophilic and has excellent tensile strength It has the ability to deliver moisture into a wound or absorb moisture This cellulose matrix is microbially derived biocompatible pyrogen-free and completely non-toxic In previous clinical trials this dressing displayed the ability to aid the natural process of autolytic wound debridement cleansing and exudate control From initial observations it appears that this cellulose matrix provides an environment that prepares the wound bed by eliminating nonviable tissue reducing bacterial burden controlling exudate and exposing healthy granulation tissue With successful wound bed preparation one can now concentrate on healing the chronic wound
This clinical trial is designed to evaluate the natural cleansing autolytic debridement process and healing attributes of this new cellulose wound dressing compared to standard of care impregnated gauze Venous ulcers have been chosen as the model because these wounds are often covered with thick fibrous non-viable tissue are poorly vascularized are contaminated with numerous bacteria and exude copious amount of wound fluid
Most clinical wound care trials to evaluate therapeutic agents for wounds have been designed to measure healing as the primary endpoint The sequence of events begins with patient examination wound classification and then the application of the test agent In most cases the test agent is placed over a wound that is contaminated with excessive bacteria needs debridement or requires wound bed preparation such as exudate control
A new wound dressing Xylos XCell cellulose wound dressing is a unique biosynthetic matrix material that is hydrophilic and has excellent tensile strength It has the ability to deliver moisture into a wound or absorb moisture This cellulose matrix is microbially derived biocompatible pyrogen-free and completely non-toxic In previous clinical trials this dressing displayed the ability to aid the natural process of autolytic wound debridement cleansing and exudate control From initial observations it appears that this cellulose matrix provides an environment that prepares the wound bed by eliminating nonviable tissue reducing bacterial burden controlling exudate and exposing healthy granulation tissue With successful wound bed preparation one can now concentrate on healing the chronic wound
This clinical trial is designed to evaluate the natural cleansing autolytic debridement process and healing attributes of this new cellulose wound dressing compared to standard of care impregnated gauze Venous ulcers have been chosen as the model because these wounds are often covered with thick fibrous non-viable tissue are poorly vascularized are contaminated with numerous bacteria and exude copious amount of wound fluid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None