The efficacy of STRATAGRAFT in adult patients with thermal burns containing intact dermal elements for which surgical excision and autografting were clinically indicated was evaluated in two randomized, open-label, intrapatient-controlled, multicenter clinical studies of 12 months duration (Study 1 and Study 2). In both studies, two comparable wound sites of each patient were selected and randomized to receive either topical application of STRATAGRAFT or autograft. Autografts served as the intrapatient control.

Study 1 enrolled 71 adult patients with acute thermal burns containing intact dermal elements (deep partial-thickness burns) involving 3 to 37% total body surface area (TBSA). The time from burn to study treatment was 1 to 18 days. The size of the STRATAGRAFT-treated wound was 12 to 960 cm2. The mean age was 44 years (19 to 79 years) with 78% male. Seventy-eight percent of patients were White, 20% were Black or African-American, and the remainder were Asian or Other. Efficacy was established on the basis of: (1) the difference in the percent area of the STRATAGRAFT treatment site and the control autograft treatment site that required autografting by 3 months following treatment, and (2) the proportion of patients achieving durable wound closure of the STRATAGRAFT treatment site at 3 months without autograft placement. Durable wound closure at 3 months was defined as wound closure at two consecutive study visits at least 2 weeks, but no more than 5 months apart, and including or encompassing the 3-month time point.

The difference in the percent area of STRATAGRAFT and control autograft treatment sites that required autografting by 3 months was 98%±17% (p<0.0001). Three patients had part or all of their STRATAGRAFT treatment site autografted by 3 months, and two of the three patients also had part or all of their autograft control study site re-grafted. Donor site harvest was eliminated for 96% (68/71) of STRATAGRAFT-treated burn sites. As a result, pain and scarring were significantly reduced at these potential donor sites that were spared and remained intact (p<0.0001). The cosmesis was similar between STRATAGRAFT-treated sites and autograft-treated sites.

The proportion of patients achieving durable closure of the STRATAGRAFT treatment site at 3 months without autograft placement was 83% (95% CI: 74, 92). The proportion of patients achieving durable closure of the autograft control treatment site at 3 months without additional autograft placement was 86% (95% CI: 78, 94).

In subgroups of race, ethnicity, sex, age, burn size in percentage of TBSA, STRATAGRAFT treatment area, and Baux scores (a scoring system to estimate mortality due to burn), efficacy results were in general consistent with the results in the overall Study 1 population.

Study 2 enrolled 30 adult patients with acute thermal burns containing intact dermal elements (deep partial-thickness burn) and involving 3 to 49% TBSA. The time from burn to study treatment ranged from 3 to 13 days. The size of the STRATAGRAFT-treated wound was 52 to 440 cm2. The mean age was 41 years (21 – 63 years). Ninety-three percent of patients were White and 7% were Black or African-American. Men accounted for 70% of the population.

Efficacy was evaluated on the basis of: (1) the percent area of STRATAGRAFT treatment site autografted by 28 days after STRATAGRAFT treatment, and (2) the proportion of treatment sites that achieved complete wound closure by 3 months. Complete wound closure was defined as ≥95% re-epithelialization in the absence of drainage.

No STRATAGRAFT treatment site required autografts by 28 days. Between 28 days and 3 months, one patient had both the STRATAGRAFT treatment site and the autograft site treated subsequently with autograft, and a second patient had 25% of the STRATAGRAFT treatment site autografted. At 3 months, 93.1% of STRATAGRAFT treatment sites and 100% of autograft treatment sites achieved complete wound closure. All STRATAGRAFT treatment sites that achieved complete wound closure at 3 months remained closed when evaluated at 6 months and 12 months after treatment.