StrataGraft is the first approved donor site–free alternative to autograft for DPT burns

Reduced or eliminated harvesting (coprimary end point)
StrataGraft eliminated donor site harvesting for 96% (68 of 71) of DPT burns in the pivotal study
Significant reduction in donor site harvesting was demonstrated by StrataGraft at month 3 as measured by percent area autografted1
- Of 71 patients studied, 3 required part or all of the area treated with StrataGraft® to be autografted1
- 2 of those 3 patients also required regrafting of the original autograft treatment site1
Difference: P<.0001.
*102% reflects the need for additional autograft (ie, regrafting) at the autograft treatment site, with 2 patients requiring regrafting.2
Achieved durable wound closure (coprimary end point) StrataGraft treatment sites achieved durable wound closure without the need to create a second wound
83% (59 of 71) of StrataGraft-treated wounds and 86% (61 of 71) of autograft-treated wounds achieved durable closure at month 3; missing data were imputed as failures1,2,*
- For patients who completed the month 3 visit, 92% (59 of 64) demonstrated durable wound closure at the StrataGraft treatment site. For reference, 95% (61 of 64) demonstrated durable wound closure at the autograft treatment site2,*
- After month 3, DPT burn wounds treated with StrataGraft demonstrated equivalent wound reepithelialization to those treated with autograft2
- 3 patients did not achieve 100% reepithelialization at month 3. However, these patients did achieve >95% reepithelialization2
*Durable wound closure was defined as 100% skin reepithelialization without drainage or dressing requirements at 2 consecutive evaluations at least 2 weeks, but no greater than 5 months, apart. At early study sessions, 100% reepithelialization was observed more frequently for autograft treatment sites relative to StrataGraft treatment sites, likely due to different mechanisms of healing.2,3
Study designClinically similar cosmesis outcomes to autograft (secondary end point) Clinically similar cosmesis outcomes to autograft—in a single procedure
Immediate, translucent coverage.4 Durable wound closure1
Images of StrataGraft treatment sites and autograft treatment sites from representative patients
POSAS observer total score (secondary end point) Clinically similar cosmesis outcomes to autograft as determined by the criteria of POSAS
At month 12, mean Patient and Observer Scar Assessment Scale (POSAS) observer total score was 15.6 for StrataGraft treatment sites compared with 16.3 for autograft treatment sites2
Each item of the POSAS observer scale is rated using a 10-point score. The total score is the sum of the first 6 scores and does not include the overall opinion.
A lower POSAS score represents a more favorable outcome
(ie, 1=normal skin, 10=worst scarring imaginable)
Vascularization
Presence of vessels in scar tissue assessed by the amount of redness6
Pigmentation
Brownish coloration of the scar by pigment (melanin)6
Thickness
Average distance between the subcutical-dermal border and the epidermal surface of the scar6
Relief
The extent to which surface irregularities are present6
Pliability
Suppleness of the scar tested by wrinkling the scar between the thumb and index finger6
Surface area
Surface area of the scar in relation to the original wound area6
Overall opinion
The overall appearance of the scar, independent of the other criteria6
These data represent individual components of a composite end point. As this study was not statistically powered to detect an effect of StrataGraft on individual components of POSAS, these results should be interpreted with caution, and no definitive conclusions regarding any individual score should be drawn.