Membrane for dressing complex wounds will enable customization of treatment

By Roseli Andrion  |  FAPESP Innovative R&D – There are some 20 million patients with complex wounds in the world, according to estimates. Regardless of the size and shape of these wounds, their complexity can make it hard to apply dressings that help them heal quickly.

A personalizable option would therefore be ideal. This is exactly what Dermbio Biotech, a startup based in Campinas (São Paulo State, Brazil) has developed, with support from FAPESP’s Innovative Research in Small Business Program (PIPE).

The product is a healing membrane for application directly on the wound. “It’s fully personalizable and doesn’t need to be cut. In contact with the wound, the membrane adheres very strongly to the affected site,” says chemical engineer Ana Flávia Pattaro, a researcher at the startup and also its chief administrative officer.

The product is particularly recommended for dressing chronic wounds, “such as bedsores in elderly people who spend long periods lying down, diabetic foot ulcers, ischemic wounds or second-degree burns, for example. It’s only inapplicable when the wound is infected and contaminated by bacteria. It's suitable for clean wounds of all kinds,” she says.

The concept is not unique. Similar products exist, but Dermbio uses a solvent with an exclusive composition. “Scientists all over the world are interested in creating a dressing that avoids contamination, loss of material and production of contaminated waste,” says materials engineer Maria Ingrid Schiavon, a partner in the startup. “No composition like ours exists. We're the only startup that promotes wound healing with these principles.”

The product must be placed directly on the wound. “Over time, the cells adhere to the material and consume it. Healing is faster thanks to this cellular proliferation,” Pattaro explains, adding that the difference is in the ingredients of the solvent, none of which is toxic to the human organism. “There are options that use the same polymer, but can’t applied it in the way we’re proposing because the product uses solvents that are highly toxic for the organism. Ours has zero toxicity and is excreted naturally by the organism.”

For Schiavon, this is the project’s main innovation. The startup estimated the quantity of this material that the organism can absorb without risking toxicity. “We found an alternative that has been sought after even by large corporations,” she says. “We succeeded in finding a material that lets the membrane be placed directly on the wound.”

The dressing is aimed mainly at patients with long-term chronic wounds. “Quality of life is the priority for these patients. The available options are mostly painful and often palliative rather than offering a solution. Our product has the potential to make the patient’s day-to-day life more comfortable. It’s painless, permits mobility, shortens treatment time, and is very cost-effective,” Schiavon says.

High performance

According to Schiavon, the startup’s product belongs to the class of high-performance dressings. “They aren’t easily found in Brazil. Our market research shows that the typical treatment strategy involves a mixture of products. There’s no such thing as a single medication that’s affordable and easy to find, and that accelerates wound healing in these cases. The patient won’t need to add various compounds to our dressing,” she says.

“Moreover, the dressing won’t need to be changed – on the contrary, it will be reusable,” Pattaro adds. Once the dressing is placed on the wound, monitoring the healing process is all that is required. “So it won't be necessary to damage the new skin that’s being formed by removing one dressing in order to replace it with another. Once the product is in place, the patient can add a little more if necessary, but won’t have to harm the new tissue as it grows. In other words, it’s much less painful for the patient, in addition to all the other benefits.”

Research on the membrane is still in progress, but the scientists have confirmed that the healing process is accelerated by use of the product. “We estimate that it will reduce the time the wound takes to heal by at least 30%,” Schiavon says.

Applicator

The product can be sprayed on the wound or placed on it using an applicator. “We call the applicator an electrospinner. It deposits the polymer solution on the wound and creates a three-dimensional structure on top to facilitate cellular adhesion,” Pattaro explains. The process can be performed at home or at a clinic. Nurses will be able to use the same applicator on several patients simply by swapping out and sterilizing the applicator tip.

They both stress the importance of offering a solution that can easily be applied. “It must be an option that helps reduce the number of patients who need to go to a clinic every day in order to continue treatment,” Pattaro says.

The idea of creating the solution arose from their experience with polylactic acid polymer (PLA). “We wanted to develop a material for use by actual patients. We were aware of the solvent challenge, but during our research we were able to find the solution,” Pattaro recalls. “By the end of the year we aim to complete the necessary trials to win approval from the national health surveillance agency [ANVISA]. We believe the product will be ready to go to market in two or three years.”

The researchers have yet to price the product, but say that the raw material is very inexpensive as it comes from sugarcane and is widely available in Brazil. The fabrication method is entirely indigenous. “We want this alternative to be adopted by the public health system [Sistema Único de Saúde, SUS], which provides care for most of the population,” Pattaro says.

Dermbio is a spinoff from the State University of Campinas (UNICAMP), and its technology and know-how were produced in the academic environment.