Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2025-09-30

Brief Summary

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Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.

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Detailed Description

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Full-thickness wounds, extending through the dermis and affecting underlying tissues, present significant clinical challenges due to their complexity and prolonged healing times. Traditional treatments include surgical debridement, dressings, and advanced therapies like Negative Pressure Wound Therapy (NPWT). Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. Studies suggest that HPTC promote cellular proliferation and angiogenesis, essential for tissue regeneration. Given the distinct mechanisms of action of NPWT and HPTC, a comparative evaluation is warranted to determine their relative efficacy in treating full-thickness wounds. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.

Conditions

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Full Thickness Skin Defects Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy

In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.

Group Type ACTIVE_COMPARATOR

High Purity Type-I Collagen based Skin Substitute

Intervention Type DEVICE

In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed

Negative Pressure Wound Therapy

Intervention Type DEVICE

In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed

Negative Pressure Wound Therapy

In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.

Group Type ACTIVE_COMPARATOR

Negative Pressure Wound Therapy

Intervention Type DEVICE

In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed

Interventions

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High Purity Type-I Collagen based Skin Substitute

In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed

Intervention Type DEVICE

Negative Pressure Wound Therapy

In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be at least 18 years of age or older.
2. Presence of a full-thickness wound of at least 4 cm² and no more than 100 cm².
3. Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit.
4. Adequate vascular supply to the affected area

Exclusion Criteria

6. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
7. The subject must be willing and able to participate in the informed consent process.

1. A subject known to have a life expectancy of \<6 months
2. Wounds with active infection / osteomyelitis requiring systemic antibiotics.
3. Presence of malignancy in the wound bed.
4. Patients with uncontrolled diabetes (HbA1c \> 9%).
5. Use of immunosuppressive therapy or systemic corticosteroids.
6. Use of other advanced wound care products within the past 30 days
7. Known allergy to fish products or components of HPTC.
8. Pregnant or breastfeeding women.
9. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
10. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
11. A subject with autoimmune or connective tissue disorders.
12. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No