There are some biologic dermal regeneration templates available in India, as evidenced by these Indian case studies using Integra and Alloderm. However, they are not widely used, with cost being the major barrier. It is suggested ADM in India typically costs 20,000 to 30,000 rupees (A$380-570) but it is unclear what quantity of ADM that represents. In this paper, it is described how a group of Indian plastic surgeons prepared their own version of a bilaminar regeneration template from hospital supply silicone gel sheet and dry collagen sheet, for use in treatment of a 2 year old burns patient, at approximately 10% of the cost of commercially available ADM.
BTM does not have an advantage over these biologic templates with respect to storage temperature. Like BTM, they can be stored at room temperature, although not at high temperatures. Cellular skin products have more storage restrictions. For example, Recell needs to be stored at 20-25°C + relative humidity 10-60% and Stratagraft for burns (human, bovine + porcine-derived), which was FDA approved last year, needs to be stored at between -70°C and -90°C.
Two obvious advantages that Novosorb BTM has over Integra in India are its much lower cost and its synthetic nature (Integra being bovine-derived). Another key advantage of BTM, as stated by Swami Raote, is its robustness in the face of infection. In Raote’s opinion, biologic competitors face failure in India because of hospital acquired infections. It is his belief that India will provide valuable validation of the robustness of Novosorb BTM.
Although hospital acquired infections (HAIs) are a problem world-wide, they are more prevalent in India. It is suggested that HAIs can occur at a rate as high as 1 per 4 hospital visits in India, compared with 1 in 20 in the United States. Burns patients are especially susceptible to HAI. A large study in a Pune tertiary hospital found a 20% rate of HAI in the burns ward. In another prospective study of 71 burn patients in Chandigarh, it was found found that up to 59 patients (83%) had hospital-acquired infections.
Like Integra, Novosorb BTM is contraindicated in overtly infected wounds and wounds must be surgically debrided to viable tissue before application (Ref IFU). But infection occuring after application is common. As described in the Integra IFU, common sources of infection after application are non-viable tissue in the wound bed, or contamination through seams or staple holes.
What matters most is the dermal template’s ability to withstand infection.
Its IFU states that infection is the most common cause for loss of Integra. Infection rates in sites treated with Integra template in the three clinical trials supporting the Integra PMA (burns) ranged from 14% to 55%. Mean take of Integra IDRT, measured across 4 large clinical studies in burns, with 1230 wound site assessed, ranged from 65.1% to 80.6%. In a separate UK hospital comparison study of Integra and Matriderm there were 11 (31.4%) major infections and 5 (14.3%) cases of complete loss of graft due to infection in the 35 patients treated with integra.
Being a more recently introduced product, Novosorb BTM is still to be tested in multiple large clinical studies. However, data to date from several smaller studies points to the product having a robust nature.
In a retrospective study of 27 patients with 35 wounds, with a range of aetiologies, including full thickness burns and necrotizing fasciitis, thirty‐three wounds were reported to have had 100% integration of BTM at the time of sealing membrane removal.
In the pilot study for the current BARDA pivotal trial in full thickness burns, results available in 12 subjects showed a mean BTM take rate of 95.22%. Mean SSG take rates available for 11 subjects were 97.53%.
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