Status:
TERMINATED
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Lead Sponsor:
Taipei Medical University WanFang Hospital
Collaborating Sponsors:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Oneness Biotech Co., Ltd.
Conditions:
Pressure Injury Stage 2
Eligibility:
All Genders
20-99 years
Phase:
PHASE4
Brief Summary
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Detailed Description
This study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of Fespixon Cream for the treatment of pressure injury in sacrum wound. The duration of this ...
Eligibility Criteria
Inclusion
- 1\. Main inclusion criteria:
- At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter
- NPUAP is classified as stage 2
- No active infection, i.e., IDSA level 1
- Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment)
- 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:
- 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
- Acute infection caused by wound ( WBC \> 12×10³/uL； or C-Reactive protein (CRP) \> 30 mg/dL)
- Liver and kidney dysfunction ( defined as \[AST or ALT\] \> 3× the upper limit of normal; serum creatinine \> 3× the upper limit of normal)
- Pregnant or lactating women
- Infected with human immunodeficiency virus
- Body mass index (BMI) less than 18.5 kg/m²
- Unable to cooperate with changing of subject's position
- Patients with anemia (Hgb \< 7.0 g/dL).
- Unable to prevent contaminations such as feces or urinary incontinence
- Malnutrition (Albumin\< 2.5 g/dL)
- Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer
- In the opinion of the investigator, entering this trial may pose a threat to subject compliance.
Exclusion
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05317442
Start Date
April 6 2022
End Date
April 19 2024
Last Update
May 1 2024
Active Locations (3)
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1
Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）
Kaohsiung City, Taiwan, 801
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
3
Taipei Medical University WanFang Hospital
Taipei, Taiwan, 10675