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

NCT06873867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-11-21

Study results available
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Summary

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.

Conditions

  • Full Thickness Skin Defects
  • Ulcer

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • Adichunchanagiri Institute of Medical Sciences, B G Nagara

    lead OTHER

Principal Investigators

  • Prema Dhanraj, MS, MCh · Rajarajeshwari Medical College and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2025-08-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873867 on ClinicalTrials.gov