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

NCT07568600 | Not Yet Recruiting DMC

• 1 other identifier: BS-2026
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Burn; Burn Contracture of Skin; Burn Degree Second

Keywords

hydrogel; epidermal growth factor; Benzalkonium chloride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pruritis

  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

Study Arms (1)

sodium hyaluronate carbomer composite hydrogel

EXPERIMENTAL

Combination Product: sodium hyaluronate carbomer composite hydrogel

Interventions

sodium hyaluronate carbomer composite hydrogel COMBINATION_PRODUCT

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

sodium hyaluronate carbomer composite hydrogel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Wenjie Ren

CONTACT

8613937354075; 13937354075@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): October 20, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share