AN OPEN-LABEL, CONTROLLED, RANDOMIZED, MULTICENTER, DOSE ESCALATION STUDY EVALUATING THE SAFETY AND EFFICACY OF STRATAGRAFT(RegisteredTM) SKIN TISSUE IN PROMOTING THE HEALING OF THE DEEP PARTIAL-THICKNESS COMPONENT OF COMPLEX SKIN DEFECTS AS AN ALTERNATIVE TO AUTOGRAFTING
Stratatech has completed a phase i/iia, dose escalation trial of StrataGraft
skin tissue in patients with complex skin defects of 5-73% total body surface area (TBSa)
resulting from thermal injury, trauma, or necrotizing fasciitis. no product-related adverse events
(ae) were seen following application of StrataGraft skin tissue to the full-thickness component
of these complex skin defects for seven days. There was no increase in the frequency or types of
ae as the dose of StrataGraft skin tissue increased 5-fold across the three cohorts from 44 cm2 to
220 cm2 (treatment area). StrataGraft skin tissue remained intact and viable throughout the
seven day placement period, suggesting the potential for continued biological activity during
longer exposure. The proposed study population has been refined to include patients with 3-49% TBSa complex skin defects including a deep partial-thickness component resulting from thermal injury. Since full-thickness and deep partial thickness components of complex skin defects are often admixed and the standard of care (excision of non-viable tissue followed by grafting of skin surgically harvested from donor sites) is identical for these wounds, the patient population in this study is anticipated to have significant overlap with the subjects evaluated in the completed phase i/iia study. The second study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored at 2-8[Degrees]C for up to eight days prior to clinical use. a third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
Two comparable wounds in each subject will be identified and randomized to receive
StrataGraft tissue or an autologous skin graft. Two donor sites will be designated in a
randomized fashion to provide a source of autograft skin for the control treatment site and, if
needed, the StrataGraft treatment site. Both the StrataGraft skin tissue and autograft control will
be placed on the treatment sites immediately after surgical excision of non-viable tissue. Safety
assessments will include wound closure of the treatment sites at three months, monitoring of ae,
vital signs, hematologic parameters, incidence of wound infection, and immunologic responses
to StrataGraft tissue. in addition, persistence of allogeneic Dna in the StrataGraft tissue-treated
sites will be evaluated at 3 months. efficacy will be assessed by evaluating wound closure of the
treatment sites, the percent area of the StrataGraft skin tissue treatment site requiring
autografting by day 28, pain of the donor sites through day 28, and the appearance of the
treatment sites, supported by clinical photography. Cosmesis of the treatment sites and donor
sites will be evaluated at 3, 6, and 12 months.
The cryopreserved StrataGraft skin tissue for the 3rd cohort will be supplied to
the clinical site. after a brief thaw, room temperature, the StrataGraft tissue will be placed in a pre-warmed thaw basin. StrataGraft tissue will then be removed , meshed at 1:1, trimmed to fit the wound and secured in place.
1. Men and women aged 18-65 years, inclusive
2. Written informed consent
3. Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting.
4. Complex skin defects of 3-49% TBSA requiring excision and autografting
5. Total burn may consist of more than one wound area
6. Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision
7. First excision and grafting of treatment sites