NCT06853210

Treatment of Pressure Ulcers Using Biological Skin Substitutes

Treatment of Pressure Ulcers Using Biological Skin Substitutes: A Comparison of High Purity Type-I Collagen and Amnion/Chorion Membranes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM)

Detailed description

Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. They are prevalent in individuals with limited mobility, such as the elderly and those with spinal cord injuries, particularly in long-term care settings. Effective management of pressure ulcers is crucial to prevent complications and improve patient outcomes, includes pressure relief, wound care, and advanced therapies such as bioengineered skin substitutes. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in promoting the healing of pressure ulcers. While both products are used in wound management, direct comparative studies evaluating their efficacy in treating pressure ulcers are limited.

Conditions

• Pressure Sore

Interventions

Type	Name	Description
DEVICE	Type-I Collagen-based Skin Substitute and SOC	The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
DEVICE	Human Amnion/Chorion Membrane and SOC	The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-07-10
• Completion: 2025-07-25
• First posted: 2025-02-28
• Last updated: 2025-08-29
• Results posted: 2025-08-29

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated device study