Clinical Trials Logo

Clinical Trial Summary

This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. The overlay is placed over the patient's bed making it easier for patients to get in and out of bed. In addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.


Clinical Trial Description

The study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers. After screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment. The mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (SNF). Patients responding to the offloading regimen (percent wound area reduction >20% at 4 weeks) may use the overlay for up to 12 additional weeks. The SOC in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05033470
Study type Interventional
Source SerenaGroup, Inc.
Contact Thomas Serena, MD, FACS
Phone 814-688-4000
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 1, 2021
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03351049 - An RCT on Support Surfaces for Pressure Ulcer Prevention N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Recruiting NCT04540822 - Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care N/A
Not yet recruiting NCT04815798 - Phage Therapy for the Prevention and Treatment of Pressure Ulcers. Phase 1/Phase 2
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01438541 - A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration Phase 4
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Recruiting NCT04251897 - Novel Support Surface to Alleviate Pressure Ulcer N/A
Completed NCT03391310 - Use of Honey for Pressure Ulcers in Critically Ill Children N/A
Recruiting NCT04559165 - Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore N/A
Not yet recruiting NCT05030935 - Assessing the Efficacy of a Prevention mHealth App Intervention for Informal Caregivers of Bedridden Outpatients N/A
Active, not recruiting NCT03048357 - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury. N/A
Terminated NCT04023981 - Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers N/A
Recruiting NCT04265170 - Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy N/A
Not yet recruiting NCT04934137 - Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users N/A
Withdrawn NCT02689817 - Monitoring Physiologic Data in the Development of Pressure Ulcers N/A
Enrolling by invitation NCT02736838 - Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns. N/A
Completed NCT03021811 - EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management N/A
Enrolling by invitation NCT02382133 - Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion N/A