BOSTON, Mass. (Ivanhoe Newswire) - Can a piece of tape cause permanent injury and scarring? If you ask some doctors and nurses who work with premature babies, you might be surprised by what you hear. A possible solution one survey has found the number one problem in neo-natal units.
We all know the feeling of ripping off a bandage, but what that adhesive does to us, is nothing compared to what it can do to infants.
"Anything from just abrasion of the skin, to actually we've heard tearing ears off of babies," Dr. Jeffrey Karp of Brigham and Women's Hospital told Ivanhoe.
Medical tape removal results in 1.5 million injuries each year. Many victims are preemies, like Iris, who rely on the tape to keep them attached to critical equipment.
"She had tubes and wires coming out of all different places," Angie Thompson, Iris's mother, told Ivanhoe.
"The problem is that neo-nats have very fragile skin and all these tapes have been tailored for adult skin," Dr. Karp explained.
"It's something we deal with every day at work," neo-natal nurse, Corrine Pryor, told Ivanhoe.
Now doctors Jeffrey Karp and Bryan Laulicht of Brigham and Women's Hospital, have a possible solution.
Dr. Bryan Laulicht demonstrates, "So that's the standard medical tape and that's the quick release tape."
Unlike regular medical tape, quick release tape is made up of three layers. The stress of removing the tape is in the middle layer, not on the skin. So, the hope is, "It won't cause any damage," Dr. Laulicht said.
It is a simple idea that could protect a lot of babies like Iris.
Over the last two years, the researchers consulted with neo-natal doctors and nurses while they developed quick release tape. It is made up of the same elements of consumer tape and medical tape. Dr. Karp tells us because of that it could be in hospitals relatively soon.
RESEARCH SUMMARY
BACKGROUND: Medical tape removal results in one and a half million injuries every year, mostly preemies. Premature babies are born before 37 weeks of pregnancy. Many premature babies need extra care in the newborn intensive care unit (NCIU). Some babies manage to make it through the NICU procedures, like IV, heel pricks, PDA ligation, central lines, tape and bandages without scars. However, there are many children that still have visible scars even as they grow toward adulthood. There have been reports of missing belly buttons, large scars across the body, and smaller scars on the neck and feet in premature babies. The scaring can be a result of many things, but the most shocking is the damages of the strong adhesive medical tape (Source: prematurity.org).
THE BANDAGE: The sticky adhesive on bandages can rip off skin and hair. The pain is more intense for premature and newborn babies. Premature babies often have IV's that need to be taped to their skin. The medical tapes most hospitals use are designed for adult skin. Even on adult skin, its painful to remove medical tape and it often leaves behind a sticky residue from the adhesive.
NEW TECHNOLOGY: During removal of current medical tapes, crack propagation occurs at the adhesive–skin interface, which is also the interface responsible for device fixation. Doctors from Brigham and Women's Hospital are developing a possible solution, quick release tape. The tape is made up of three layers. There is a layer in between the adhesive and the backing layers, the anti-adhesive composite intermediary layer. Current medical tape fracture at the adhesive skin interface, but with the quick-release tape the fracture zone is transformed away from the skin and concentrated on the middle layer. The anisotropic properties of this middle layer means that it has different physical properties dependent on direction. The researchers employed a release liner to create the anisotropic interface, resulting in a medical tape with strength and low peel force for safe, quick removal. (Source: National Academy of Sciences of the United States of America) Researchers hope that this new tape will prevent injuries in premature babies as well as the elderly who have sensitive skin.
INTERVIEW
Jeff Karp, PhD, Associate Professor at Harvard Medical School and Co-Director of the Center for Regenerative Therapeutics at Brigham and Women's Hospital talks about a new adhesive tape for neonates.
What is the latest thing that you're working on that people don't even think about?
Dr. Karp: About three years ago for the Institute for Pediatric Innovation I did a survey of several neonate units across the country and they determined that the number one problem facing the neonate units was adhesive tapes. So these neonates are constantly wrapped in medical tape and all of these tapes have been tailored for adult skin. And one of the big challenges is that these tapes are required to adhere tubes and devices to these neonates. The problem is, is when you go to remove the adhesives, they can actually induce significant damage to the skin. So the skin can be torn and leave behind scars that can be incredibly devastating.
They can be simple cuts but also scarring, fibrosis, even deformity in some cases, right?
Dr. Karp: Right, so these can be from anything, from just abrasion of the skin to actually we've heard tearing ears off of babies. Unbelievable!
And then what happens?
Dr. Karp: To solve this problem we put together a series of design criteria. We wanted to work with components that already existed in adhesives so we wouldn't have to have significant regulatory hurdles to get this in to the clinic. We also wanted the material to be scalable, we wanted it to get in to the clinic as quickly as possible, and we wanted it to be able to secure the devices to the skin but when we removed it we didn't want to induce any damage.
So how did you solve the problem?
Dr. Karp: One of the big challenges with existing adhesives is there's really two components. There's a backing layer which you see when the bandage is on your skin and there's an adhesive layer. And what happens is that the adhesive layer adheres to the skin and it allows the backing to remain in place and provides the mechanical support to keep devices in place. When you go to remove these adhesives what happens is that the fracture typically happens at the interface of the skin and the adhesive. And so with adult skin this often happens right at the adhesive and so some adhesive is left on the skin. I think most people can relate to removing bandages and having some adhesive remain. The problem is that neonates have very fragile skin and so the point of least resistance is in their skin not in the adhesive. So when you go to remove the bandage the skin tears and this is a major problem.
So how did you solve this?
Dr. Karp: The problem with neonate skin is that it's just very fragile and can be easily torn and damaged. So we posed the question could we actually transition the fracture zone away from the interface between the skin and the adhesive and that way we could significantly reduce damage during removal. And so we came up with this idea to have a middle layer, so we have an adhesive layer and we have a middle layer and then we'd have the backing. And what we developed, an approach whereby when the adhesive is removed the fracture occurs between the backing and this middle layer.
You said some of the components are the same as the adhesive you already use so what is the difference beside the middle layer?
Dr. Karp: The part that contacts the skin is identical and there's a range of adhesives that we can use that have already been tested against skin, so there's that part. Essentially the materials that we've used are identical to what are used in current tapes. We've just found a new way to fabricate the tape so we can actually transition the fracture away from the skin interface to the backing interface.
How long did this process take, and how did you engineer the middle layer?
Dr. Karp: This took us on the order of about a year, a year and a half to really get the process down. Most people would be familiar, when you have a bandage and you go to apply it on the skin you first remove these paper pieces from the bandage and they're actually attached directly to the adhesive. They're actually anti-adhesives so you remove them. What we decided to do was to take the backing layer and use that same coating on the inner side of the backing layer so we made it anti-adhesive. So if you place this now on top of an adhesive it won't stick very well. It can easily peel off. Now the adhesive can strongly attach to the backing layer. So we etched with a laser this anti-adhesive layer to expose different regions of the backing and that way we could exhibit control over the interaction between the adhesive and the backing.
You talked about the one point five million bandage injuries encountered, every year?
Dr. Karp: Right per year.
Were you surprised when you heard that?
Dr. Karp: There's an incredible number of incidences of damage done by removal of bandages from the skin. It's somewhere on the order of one point five million per year. And a significant number of these happen in the neonate units. Just an astonishing number.
We're talking sensitive skin, fragile skin so it's not just for neonatal it's also for other people with sensitive skin?
Dr. Karp: As you age your skin gets more fragile and we think that these tapes could also be very useful for the elderly.
When do you think it could go to market?
Dr. Karp: We think that because we've used materials that exist in adhesives and we've really kept an eye on potential scalability of the approach, the process we have developed could be very quickly scaled. We think this could get to market very fast. The adhesive glues remains the same and are used today in the neonate units as well as on adults. And so we think all that's required is really a few clinical studies just to demonstrate that this indeed works in relevant context and then we could rapidly get this into neonate units.
Does regular medical tape have to go through FDA approval or clinical trials?
Dr. Karp: I don't think that medical tapes for the skin require extensive clinical trials.
Does this have to be FDA approved or does it just go to trial?
Dr. Karp: Right, Typically bandages are class one devices they don't require clinical trials, however we probably would want to do a clinical study on neonates. It's challenging to set up that type of a trial because of the nature of neonates. What's really critical to consider here is that the adhesive that contacts the skin is exactly the same as the adhesive that exists in commercial bandages. So there's no concerns about toxicity as we haven't introduced anything new. It's just a matter of how the adhesive fractures when you remove it from the skin. So you know it's a very, very simple design change but it could be an incredibly, meaningful and powerful solution for these patients.
Anything else you want to add?
Dr Karp: Bryan Laulicht the first author on the paper received the MIT Technology Review TR35 award and Robert Langer at MIT was a close collaborator on this work. We also worked with Children's Mercy Hospital in Kansas City.
They're your partners in the study right?
Dr. Karp: We consulted with them and they provided extensive background information on existing adhesives used in neonate units as well as what has been tried and failed in this space.
So this hasn't been tried on any babies at this point?
Dr. Karp: No.
Did you get input from the neonatal nurses and doctors?
Dr. Karp: We did. That was actually very critical to developing a relevant solution. We had frequent conversations with neonate nurses and doctors from Children's Mercy Hospital to really provide us with information as to what are the existing adhesives that are used, what are some of the design criteria that we need to consider. And this was very important to us to develop an effective solution that wouldn't just be something that would end up in an academic journal, but would actually have potential of being translated to the clinic very quickly.
FOR MORE INFORMATION, PLEASE CONTACT:
Jeff Karp, PhD
Associate Professor at Harvard Medical School and Co-Director of the
Center for Regenerative Therapeutics at Brigham and Women's Hospital
(617) 817-9174
jeffkarp@mit.edu
