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Home > Clinical Trials By Condition > Burns > Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds
Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds

Overview:


Status: Not yet recruiting
Study State Date: October 2012
Primary Completion Date: Anticipated December 2016
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase: Phase 2

Sponsor(s): Lonza Walkersville, Inc.

Information By: Lonza Walkersville, Inc.
Trial Identifier: NCT01655407
Official Title: Evaluation of Autologous Engineered Skin Substitute (ESS-W) Compared to Meshed, Split-Thickness Autograft (AG) for Treatment of Deep Partial- and Full-Thickness Thermal Burn Wounds in Adult Patients

Description: The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds. The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will be performed by taking healthy skin from one area of the body and placing it on the burned area.

Eligibility:

Accepts Healthy Volunteers?: No
Enrollment: 10 Anticipated
Minimum Age: 18 Years
Maximum Age: 40 Years
Gender(s): Both
Additional Criteria: Inclusion Criteria: - Has deep partial or full-thickness thermal burns ≥50% of the TBSA and fulfills the total grafting area requirement ranging from 288 cm2 up to 5,600 cm2, divided between two (or more) recipient sites. - Is expected to require multiple skin grafting procedures. - Is ≥18 years and ≤40 years of age at the time of enrollment. - Females of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use appropriate birth control methods during the pre-grafting period and for three months following the last Grafting Day. - Subject (or a legally authorized representative (LAR)) has provided written informed consent for study participation and procedures to be performed. Exclusion Criteria: - Has a current diagnosis of septic shock or Multiple Organ Dysfunction Syndrome, which in the opinion of the Investigator would put the potential subject at risk of serious morbidity or death by participating in the study. - Has a current diagnosis of an invasive burn wound infection in unexcised burn wound. - Is pregnant. - Is a prisoner at the time of obtaining written informed consent. - Has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of ESS-W including the irrigation solution used before and after grafting. These include aminoglycosides, polymyxin B, mupirocin, ciprofloxacin, amphotericin B, hydrocortisone, and insulin. - Has a documented history of allergy or sensitivity to any of the animal products used in preparation of ESS-W. These products include bovine blood, bovine collagen, bovine collagenase, and porcine trypsin-versene. - Has a documented history of allergy or sensitivity to glycosaminoglycan, the polymer component of ESS-W. - Has a documented ongoing condition which could delay wound healing such as insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C). - Has a severe malnutrition or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing.

Conditions:
Burns
Thermal Burn Wounds
Interventions:
Drug: Autologous Engineered Skin Substitute (ESS-W)
Drug: Meshed Split-Thickness Autograft (AG)

Primary Outcome Measures: Incidence and severity of infections at grafting sites
Time Frame: Up to Month 6 after the last grafting day
Safety Issue: Yes

Incidence of re-grafting
Time Frame: Up to Month 6 after the last grafting day
Safety Issue: Yes

Incidence of adverse events that are related to study treatment and associated with the grafting site
Time Frame: Up to Month 36 after the last grafting day
Safety Issue: Yes

Incidence of all adverse events.
Time Frame: Up to Month 36 after the last grafting day
Safety Issue: Yes

Percentage engraftment as determined by the Investigator through clinical assessment
Time Frame: Up to Month 3 after the last grafting day
Safety Issue: No

Percentage engraftment as determined by an independent observer through clinical assessment
Time Frame: Up to Month 3 after the last grafting day
Safety Issue: No

Confirmation of engraftment by histological assessment
Time Frame: Up to Month 6 after the last grafting day
Safety Issue: No

Percentage of wound closure as determined by blinded computerized planimetric assessment
Time Frame: Up to Month 3 after the last grafting day
Safety Issue: No

Percentage area of re-grafting as determined by blinded computerized planimetric assessment
Time Frame: Up to Month 6 after the last grafting day
Safety Issue: No


Secondary Outcome Measures: Scar outcome assessment using the modified Vancouver Scar Scale (mVSS).
Time Frame: Up to Month 36 after the last grafting day
Safety Issue: No

Incidence and severity of post-burn pruritus utilizing a validated patient self-assessment instrument
Time Frame: Up to Month 36 after the last grafting day
Safety Issue: No

Incidence of contracture release or revision surgeries
Time Frame: Up to Month 36 after the last grafting day
Safety Issue: No

Incidence of increased temperature sensitivity
Time Frame: Up to Month 36 after the last grafting day
Safety Issue: No

Incidence of paresthesias, pain, dulling of sensation assessed through patient self-reporting scale and by monofilament testing
Time Frame: Up to Month 36 after the last grafting day
Safety Issue: No


Patient Groups:Assigned Interventions:
Treatment: Experimental
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG). Drug: Autologous Engineered Skin Substitute (ESS-W)


Drug: Meshed Split-Thickness Autograft (AG)



Control: Active Comparator
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG). Drug: Autologous Engineered Skin Substitute (ESS-W)


Drug: Meshed Split-Thickness Autograft (AG)




Location & Contacts:

Contacts:
Kush Dhody, MBBS, MSc (301) 956-2536 kushd@amarexcro.com

Investigators:
Study Director: Michael Peck, MD, The Arizona Burn Center


Study Locations:
+ Show All 2 Study Locations
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