Clinical Trials Logo
  1. Home
  2. Wound Heal
  3. NCT04979637

Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study — INDICATE  

Wound Heal Clinical Trial

Official title:
A Multi Centre, International, Analytical Performance Study of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.

Clinical Trial Description

One of the biggest challenges in wound care today is the accurate and timely diagnosis of infection in complex wounds. Despite efforts, it still remains difficult to determine whether complex wounds are infected or not. There is no single gold standard for wound infection: clinicians use a multitude of methods in addition to the history and their examination to reach an overall conclusion as to potential wound infection status - each with its own strengths and weaknesses (associated performance characteristics). To aid accurate and timely detection of wound infection in clinical practice, ConvaTec and partners have developed a new technology intended to detect infection biomarkers. This is based on the combined measurement of the following three biomarkers: wound pH, and activity of human neutrophil elastase (HNE) and myeloperoxidase (MPO) host enzymes. The overall aim of this proof of concept study is to demonstrate that the three infection biomarkers (HNE/MPO/pH) surpass clinical judgement in detecting infection status using a standard of reference. The primary objective of the proof of concept study is to demonstrate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy. The secondary objective of the proof of concept study is to explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04979637
Study type Observational
Source ConvaTec Inc.
Contact
Status Withdrawn
Phase
Start date July 1, 2021
Completion date December 23, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Recruiting NCT03459547 - Soft Peri-implant Tissue Around Different Abutment Materials N/A
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Completed NCT03285542 - Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty N/A
Recruiting NCT05474911 - PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY. N/A
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT04849143 - The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation N/A
Completed NCT03596112 - The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care N/A
Recruiting NCT05169814 - Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds Early Phase 1
Completed NCT04545476 - Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities N/A
Completed NCT06020157 - Comparison of Simple and Continuous Suture Techniques in Oral Surgery N/A
Recruiting NCT05133570 - Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Recruiting NCT04901325 - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) Phase 2
Withdrawn NCT03668665 - Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design" Phase 3
Completed NCT03703479 - Effect of A-PRF After Removal of Wisdom Teeth N/A
Recruiting NCT03204851 - Microlyte Dressing in the Management of Wounds N/A
Recruiting NCT06117436 - Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients Phase 2/Phase 3
Completed NCT05618912 - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment N/A