Fespixon Cream for the Treatment of Pressure Injury in Sacrum Wound

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the efficacy and safety of Fespixon cream for the treatment of pressure injury in sacrum wound.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Medical University WanFang Hospital
• Collaborators: Kaohsiung Medical University Chung-Ho Memorial Hospital; Oneness Biotech Co., Ltd.

Criteria

1. Main inclusion criteria:

1. At least 20 years old, less than 85 years old, with pressure wounds located in the sacral vertebrae

2. NPUAP is classified as level 2

3. No active infection, i.e., IDSA level 1

4. Ulcer area should be 4-25 cm^2

5. If an artificial ostomy is not performed, the distance between the target ulcer and the anus must be greater than 5 cm to prevent contamination

2. Main exclusion criteria:

1. Those who have an allergic reaction to the ingredients of this product, including those who have been allergic to sulfa drugs, Plectranthus amboinicus, Centella asiatica or excipients

2. Acute infection caused by wound ( WBC > 11000/μL； or C-Reactive protein (CRP) > 30 mg/dL

3. Liver and kidney dysfunction ( GOT/GPT: 126/120 IU/L, creatinine: 2 mg/dL)

4. Pregnant or lactating women

5. Infected with human immunodeficiency virus

6. Body mass index (BMI) less than 20 kg/m^2

7. Unable to cooperate with changing of subject's position

8. Patients with anemia (Hgb < 7.0 g/dL).

9. Unable to prevent contaminations such as feces or urinary incontinence

10. Malnutrition (Albumin< 2.5 g/dL)

11. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer