005: Trial of the Available Technology Dressing for Resource Limited Settings       
Submission Category: Clinical Research       
Submitter and Primary Author: Linda Benskin, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA, WOCNF

Co-Author: Richard Benskin - Research Associate, Benskin Research Group

Introduction 

Clinicians need a safe, effective, affordable, available, acceptable, easy-to-use dressing solution to teach wound self-care patients where funding, sanitation, and climate control is lacking. 

Our quest to provide an evidence-based solution for wound management in the most challenging environments led to published literature reviews in 2013. Improvised dressings used in India, Ghana, Uganda, Japan, Australia, Angola, and the USA on burns, surgical wounds, leg ulcers, and pressure injuries provided context. Using a Wound Healing Foundation small grant. We trialed our idea on sickle cell leg ulcers (SCLUs) in the tropics in 2021. 

SCLUs are so challenging to close that usual practice world-wide is wet-to-dry gauze or dry gauze over ointment; more sophisticated dressings have not improved outcomes. 

Methods 

This three-armed 12-week evaluator-blinded randomized controlled trial compared:

1) A negative control (wet-to-moist dressings; WTMs); superior to usual practice because it promotes moist healing and removal is less traumatic   

2) ATDs: cut-to-fit perforated (with slits) food-grade plastic with a periwound moisture barrier; covered with an absorbent 

3) A positive control (polymeric membrane dressings; PMDs); the advanced dressings with the strongest evidence for use a tropical setting 

All three protocols were rigorously defined. The patients conducted their own dressing changes and submitted data weekly via WhatsApp, with monthly clinic visits. 

Results        
All groups’ mean healing and quality of life scores improved. These scores improved more for ATD than WTM participants. Participants found ATDs easy-to-use and highly acceptable. Complications were limited to mild pseudomonas infections with WTMs, successfully treated with dilute vinegar (25% WTM vs 0% ATD and 0% PMD). ATD-managed wounds decreased in size more often than WTM (92% vs 50%). ATDs were not dramatically inferior to PMDs, and were significantly less expensive, but were more time-consuming.        

Discussion       
ATDs are affordable, available, acceptable, easy-to-use, effective, and safe, even in the tropics.    

010: Results of a Clinical Study Utilizing a Novel Contemporary Designed Medical Device for the Prevention and Treatment of Hospital Acquired Tissue Injuries.  
Submission Category: Clinical Research  
Submitter and Primary Author: Michael Jay Marcus, DPM, FACFAS – Adventist Hopsital Montebello, Greater El Monte Community Hospital 

Introduction 

Hospital acquired pressure injuries affect approximately 2.5 million individuals every year in United States acute care facilities. These wounds represent an enormous burden on global healthcare from both a patient care and a budgetary perspective.

Currently, there is a gap in the landscape of devices available for prevention and treatment of these lesions. There exist many shortcomings that range from inefficient offloading to cumbersome design.

The HeelSphere is a newly patented medical device that is cost effective and efficiently provides offloading of the foot and ankle to prevent and treat these injuries.

Methods

An IRB approved user study was implemented at our  community hospital setting. It involved 28 patients. Two different density devices were utilized and randomized assigned within the protocol. Patients were monitored for 72 hours to assess the effectiveness of the device. Our investigator collected various datas points,  including but not limited to the offloading  distance of the heel to the bed surface, as well as the position of the device with relationship to the distance from the malleoli. Observation for any skin change  or reaction secondary to the use of the device was documented as well.

Results 

Based on the data collected and evaluated by our statistician, the device proved suitable for use for offloading of the foot and ankle. The HeelSphere statistically provided effective heel offloading. In 93% of the patients the device proved to be comfortable. Throughout the study, there were no reported skin conditions or medical device related tissue injuries as a direct result of the utilization of this device. Data collected from HCP indicated that the device was easy to use and provided effective offloading.Slight variation was seen between the two densities with reference to surface cracking. (BMI relationship).

Discussion

This newly patented device provides efficient offloading and can be effectively used in the treatment and prevention of HAPIs. Based on its global design it allows for motion of the leg. It is strapless , orange in color, easy to apply, compatible with compressors, facilitates easy observation, lightweight, allows for air flow, and has sensor capabilities .

Allowing for easier healthcare access to the wounds and allowing patients to turn in their beds without compromising offloading.The device is also vacuum packaged allowing for easier accessibility .

Trademarked Items   
HeelSphere (TM ) US Patent design and utility-11,877,960