Trials / Completed
CompletedNCT07383519
Application of Photon Therapy Instrument Combined With Ultrasonic Debridement in Senile Third and Fourth Stage Pressure Injuries
Dahua Hospital, Xuhui District, Shanghai
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- Dahua Hospital, Xuhui District, Shanghai · Other Government
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
These findings support the integrated use of ultrasonic debridement and photon therapy as a beneficial treatment strategy for advanced pressure injuries in elderly patients, demonstrating its value in improving both clinical results and overall patient well-being.
Detailed description
This study assessed the clinical effectiveness of combining ultrasonic debridement with photon therapy for treating stage 3 and 4 pressure injuries in elderly patients, with particular attention to wound healing, pain reduction, and quality of life outcomes. We enrolled 118 elderly patients with pressure injuries from Shanghai Dahua Hospital between May 1, 2023, and November 30, 2024, using stratified random sampling. Participants were first grouped by injury stage (3 or 4) and then randomly assigned to either control or experimental groups. Control patients received standard moist wound care alongside systemic interventions, whereas the experimental group received the same standard care plus combined ultrasonic debridement and photon therapy. We compared outcomes including wound healing progress, treatment expenses, and pain scores recorded during dressing changes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Photon Therapy Combined with Ultrasonic Debridement Group | Participants in this arm received the combined intervention of ultrasonic debridement followed by photon therapy in addition to standard moist wound care and systemic management. Ultrasonic debridement was performed using a handheld device held at a 45-degree angle approximately 0.5 cm from the wound surface to selectively remove necrotic tissue. Subsequently, photon therapy was administered with the light source positioned 10 cm from the wound for 15 minutes per session, using blue light (for infected wounds) followed by red light as indicated. This combined physical therapy regimen aimed to enhance wound bed preparation, reduce bacterial load, promote tissue repair, and accelerate healing in elderly patients with stage 3 or 4 pressure injuries. |
| OTHER | Standard Wound Care Group | Participants in this arm received standard moist wound care guided by the TIME principle (Tissue management, Infection/inflammation control, Moisture balance, and Edge advancement) and systemic interventions. Wounds were cleansed with 0.9% normal saline, and appropriate dressings were selected based on wound stage and exudate level. Dressing change frequency was determined according to clinical need. Systemic factors affecting wound healing were addressed, and comprehensive health education was provided, including guidance on repositioning, nutrition, and home care. This arm served as the control to evaluate the added benefit of the combined physical therapy intervention. |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2024-07-30
- Completion
- 2024-11-30
- First posted
- 2026-02-03
- Last updated
- 2026-02-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07383519. Inclusion in this directory is not an endorsement.