Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel

Development and Preclinical Study of Nursing Dressing for Ⅰ/Shallow Ⅱ Degree Burn Wounds Based on Sodium Hyaluronate Carbomer Composite Hydrogel

Development and clinical study of burn wound nursing dressing based on sodium hyaluronate carbomer composite hydrogel

Study Overview

• Status: Not yet recruiting
• Conditions: Burn; Burn Degree Second; Burn Contracture of Skin
• Intervention / Treatment: Combination product: sodium hyaluronate carbomer composite hydrogel

Detailed Description

Development and preclinical study of nursing dressing for Ⅰ/shallow Ⅱ degree burn wounds based on sodium hyaluronate carbomer composite hydrogel

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenjie Ren; Phone Number: 8613937354075; Email: 13937354075@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Partial or full thickness burns requiring split thickness skin grafts Target burn wound size between 10 cm² and 1000 cm² Age ≥ 18 years Ability to read, write, and speak German Provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations Informed consent will be obtained from the patient or from a legal representative if the patient is not able or competent to consent; in such cases, informed consent will also be obtained from the patient when he/she regains competence Women of childbearing potential must test negative on a standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e.g., oral contraceptive, intrauterine device [IUD], intramuscular contraceptive, abstinence)

Exclusion Criteria:

Target wound has exposed hyaline cartilage Connective tissue disorder Previous skin graft failure at target wound site Total burn surface area ≥ 70% Infected target wound Immunosuppression therapy Chronic hemodialysis Steroid use Diabetes (Type I) Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X Allergy or sensitivity to chlorhexidine Pregnancy Simultaneous participation in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sodium hyaluronate carbomer composite hydrogel	Combination product: sodium hyaluronate carbomer composite hydrogel; Development and preclinical study of nursing dressing for Ⅰ/shallow Ⅱ degree burn wounds based on sodium hyaluronate carbomer composite hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft neo-epithelisation	Complete neo-epithelisation is defined as 100% coverage of the grafted burn wound area by new epithelial tissue without any residual open wound, as determined by two independent blinded assessors using standardized clinical photography combined with digital planimetry software (ImageJ or equivalent). Wound images will be captured at baseline (Day 0) and at each follow-up visit (Days 7, 14, 21, 28, 35, 42, 50) using a standardized photography protocol (fixed camera distance, lighting, and anatomical reference markers). The percentage of wound area achieving complete neo-epithelisation will be calculated as: (area of neo-epithelialized tissue / total initial wound area) × 100%. The primary endpoint is the proportion of participants achieving complete neo-epithelisation by Day 50.	50 days. Metric for Summarizing Data: Number and percentage of participants achieving complete neo-epithelisation by Day 50 Mean (±SD) and median (IQR) time to complete neo-epithelisation Rate of neo-epithelisation (% wound closure per day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritis	Pruritus (itching) severity will be assessed using the Numerical Rating Scale (NRS), a validated self-reported scale where participants rate their worst itching intensity over the past 24 hours on an 11-point scale ranging from 0 (no itching) to 10 (worst imaginable itching). Participants will complete the NRS assessment daily from Day 0 (baseline, prior to dressing application) through Day 50. The primary metric for this outcome is the mean change from baseline in NRS score at Day 50. Secondary metrics include: (1) the proportion of participants achieving a clinically meaningful reduction in pruritus (defined as ≥ 4-point decrease from baseline or NRS score ≤ 3); (2) time to onset of pruritus relief (first day with ≥ 2-point decrease maintained for ≥ 3 consecutive days); and (3) area under the curve (AUC) of NRS scores over the 50-day study period. Higher scores indicate worse pruritus severity.	50 days. Metric for Summarizing Data: Mean (±SD) change from baseline in NRS score at Day 50 Median (IQR) change from baseline Number and percentage of participants with ≥ 4-point reduction or NRS ≤ 3 Median time to pruritus relief AUC of NRS scores

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xinxiang Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): October 20, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hydrogel; Benzalkonium chloride; epidermal growth factor
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: BS-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No