NCT06280053

HealiAid in the Treatment of Different Wounds

The Clinical Safety and Effectiveness of HealiAid Collagen Wound Dressing in the Treatment of Different Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Maxigen Biotech Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds. The main questions it aims to answer are: 1. The wound healing which was defined as the percentage of area change. 2. The duration of wound healing. 3. The granulation tissue growth of the wound. 4. The wound exudate. 5. Safety Indicators of which incidences after treatment. HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks.

Detailed description

An open-label study will be performed in single center to monitor about 6 patients in each types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds, totally 24 patients, after the treatment of using HealiAid Collagen Wound Dressing (MAXIGEN BIOTECH INC., Taiwan) directly on the wound sites. Follow-up visits will be at 1, 2, 4, 8 and 12(if needed) weeks after the treatment. The primary endpoint of this study was the area percentage of healed wound at the 8-week post-treatment interval, which is also considered as the healing condition of the wound. The secondary endpoints of this study were included the duration of wound healing, granulation tissue growth, wound exudate, and the incidence of safety events. T-test or Wilcoxon rank-sum test will be used to test for the differences between baseline and each visit. Statistical significance was established at p \< 0.05. The actual enrollment of this study was 6 participants each in the venous ulcers, bedsores, and burn wounds, while no patients with diabetic foot wounds were recruited, resulting in a total of 18 participants.

Conditions

• Venous Ulcers
• Bedsores
• Diabetic Foot Wound
• Burn Wound

Interventions

Type	Name	Description
DEVICE	HealiAid Collagen Wound Dressing	HealiAid is an absorbable collagen wound dressing. It is fabricated by fibrous collagen matrix, in which the collagen is purified from bovine Achilles tendons. HealiAid can be applied easily by covering directly to the clean wound sites.

Timeline

• Start date: 2016-03-02
• Primary completion: 2018-04-11
• Completion: 2018-10-26
• First posted: 2024-02-28
• Last updated: 2024-02-28