Burns Clinical Trial
Official title:
Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects In Patients Undergoing Sequential Skin Reconstruction Procedures
Verified date | December 2018 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot Phase I/II clinical study will be conducted at up to three clinical sites.
This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients,
each with skin defects. The patients are intended to undergo sequential surgical procedures
involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at
various separate or contiguous wound sites. Patients will be randomized within each wound
site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
Status | Completed |
Enrollment | 15 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged greater than 18 yrs. - Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting - Full-thickness skin defects - Informed consent Exclusion Criteria: - Prisoners - Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females - Immunosuppressive therapy - Infection with Human Immunodeficiency Virus - Venous stasis ulcers of the lower leg - Diabetic foot ulcers - Donor site wounds - Wounds of less than 5% body surface area - Wounds of the hands, face, and feet (although such wound surface areas can be counted toward total injured BSA) - Prior entry into this study - Expected survival of less than 3 months - Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, other serious or unstabilized organ damage from trauma, etc.) - Use of an investigational agent within 30 days - Active malignancy - Clinical evidence of malnutrition - Clinically significant renal, hepatic, cardiac, pulmonary, or neurological impairments |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin-Hospital and Clinics | Madison | Wisconsin |
United States | Arizona Burn & Trauma Center | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Stratatech, a Mallinckrodt Company | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Centanni JM, Straseski JA, Wicks A, Hank JA, Rasmussen CA, Lokuta MA, Schurr MJ, Foster KN, Faucher LD, Caruso DM, Comer AR, Allen-Hoffmann BL. StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: — View Citation
Schurr MJ, Foster KN, Centanni JM, Comer AR, Wicks A, Gibson AL, Thomas-Virnig CL, Schlosser SJ, Faucher LD, Lokuta MA, Allen-Hoffmann BL. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009 Mar — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue. | The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue. | two weeks post-autografting | |
Secondary | Appearance of Allograft Tissues | The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points). | StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject. | |
Secondary | Viability of Allograft Tissues | Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells. | At the time of allograft removal (~7 days) |
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