Severe Problems with SRT wounds healing.

I have suffered through the same problem, and I have posted and cautioned others on the Mayo Squamous Cell (SCC) Treatment group to not consider this as a treatment alternative for SCC for legs. My posts were in response to Mayo patients seeking alternatives to Moh's.

You are suffering because the medical device manufacturer recommends this treatment despite the fact it is not indicated for the treatment of legs. I have conducted considerable research on the studies for this treatment and would be pleased to share my information with you.

In order to prevent this from happening to other patients, I would encourage you to look at the adverse injuries on the FDA Maude Database. If you search under manufacturer, "Sensus Healthcare", with a date range from 2016 to present, you will find the majority of adverse events relate to SRT injuries to legs. I filed a voluntary patient adverse event report on the FDA Maude database in October 2022 and provided updates in January and April 2023.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

My SRT injury was on the right tibia. I also had Hyperbaric (HBO) treatments and was at one point hospitalized due to wound complications. I can report that my wound eventually healed, I was under the care of a small wound center and transferred to a major University Hospital Wound Care Center.

Unfortunately, we are not alone in this issue, and I really feel terrible that you are suffering from SRT. Both wound centers that treated me reported they had previously treated SRT leg injuries. I came across a blog by Caroline Fife, MD entitled "Stop the Madness of Radiation to the Shin", showing this is not an isolated problem.

I would be pleased to communicate and share my research with you if you want to correspond. I appreciate the pain and frustration you are experiencing and hope you will see some improvement from your treatments. I regularly monitor the Mayo site and post information in the hope that others do not choose SRT for treatment of their legs and do not have to endure the same suffering.

@johninocalaflorida, I hope you saw the helpful post from @thomasgrove. Your shins look terribly painful. I'm glad you are seeing some improvement with wound suction. Are you seeing a wound nurse specialist at a wound clinic?

I go to a wound clinic near me twice a week. The APRN and her Tech. change the dressing, debride the wounds if needed and apply a new suction sponge and sponge bridge between the two wounds. All of this is secured with a tape film and Dermabond.

She the sets the Genadyne suction pump up with hoses. I carry it around with a strap over my shoulder or set it next to me while I am driving, sitting or sleeping. The only time I don't have it connected is when I shower. I have a knee high rubber boot that keeps the lower part of my leg dry.

The whole thing is a "PITA" but as a result, after 8~9 weeks we are seeing positive but slow results.

I have been dealing with this whole ordeal for over a year and tell you I am growing tired of it.

Thanks for your concern.

Thomas,

Thanks for your reply...at least I know I am not the only one that has experienced this "insanity".

I chose SRT be cause I had good experience with it on other parts of my leg and wanted to avoid the cutting and "gymnastics" associated with Moh's.

I think a big part of the problem that I am having is due to 1) Lack of training of the staff that treated me, 2) Lack of supervision and 3) the Provider/Location that I went to for SRT had recently been sold to a large out of state firm that brought in staff that I did not know and were not familiar with the procedures and equipment they were using.

I really never felt comfortable with the whole process. Hind sight being 20/20 I should have pulled the plug on this early on...but I trusted my Dr's/Staff. I have to remember to follow my gut.

How long did it take you to reach a final resolution? I have been dealing with this for over a year and it has disrupted my life.

Thanks for your advice and concern.

John,

I found the treatment of SRT induced wounds to be subjective and difficult. I obtained a copy of Sensus' Operating Manual (DRC-2016-012922), it states: “Clinicians should therefore be aware that exceeding 500 cGy per fraction in areas of low vascularity could lead to perforation of the lysosome membrane and the deposit of enzymes into the cytoplasm, resulting in cell death. This is a particular concern on lower limbs, where slow healing process is evident due to dermal shutdown" (page 63).

I had nearly lost hope that I would ever heal. I had a normal Pulse Volume Recording (PVR) and a vascular surgeon doppler study showing I did not have circulatory issues in my leg and no circulatory back-wash. A baseline test was taken in the hyperbaric chamber called a Transcutaneous Oxygen Study (T-COM), 0.9 mmHg Regional Perfusion Index, which was extremely low. This indicated damage caused by radiation to the tissue, similar to the statement in the Sensus Operating Manual.

I completed the hyperbaric (HBO) treatments in October 2022. In February 2023, 11-months after my last SRT treatment and 3-1/2 months after HBO, the wound slowly started to shrink. Once this started, it took about 4 more weeks before the Wound Center was willing to release me.

In total, my Squamous Cell lesion resulted in 117 visits to the Doctor. I have attached some photos showing the progression of the wound injury, which I included in my Patient Adverse Event filing with Food and Drug Administration.

The debridement's were extremely painful and the daily regime of applying the dressings to the wound was a hassle. Hopefully, you will see some improvement and can look forward to having a normal hot shower without having to keep your leg dry.

I have you in my thoughts.