Research on the Key Technology of Burn Wound Treatment

A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment

Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially on the early treatment of deep second degree burns. The prognosis of burns is of great difference. In recent years, the promotion of wound repairing technologies provides a new opportunity for improving the quality of wound healing and solving the problem of scar formation. Although some new methods and techniques have shown significant efficacy in clinic, clinical researches with large samples conducted in multiple centers are still deficient, impeding the evaluation of their superiority. Therefore, the current protocol focuses on the repair of deep second degree burns based on previous researches. There are four types of treatment protocols for wounds. Patients were divided into four groups randomly, including regular dressing change group, controlled debridement + biological dressing covering group (xenogeneic acellular dermal matrix), controlled debridement + epidermal cell cultivation group, controlled debridement + bFGF treatment group. The wound healing rate, healing time and scar formation were observed. The availability and security were evaluated. Further more, treatment guidelines and expert consensuses on deep second degree burn wounds were concluded. Above studies are important to promote the treatment of deep second degree burns to be scientific, standardized and professional in China.

Study Overview

• Status: Unknown
• Conditions: Burn
• Intervention / Treatment: Procedure: Routine dressing change; Procedure: Limited debridement & Acellular dermal matrix dressing; Procedure: Limited debridement & Epidermal cell spraying; Procedure: Limited debridement & Basic fibroblast growth factor

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Area of deep second burn wound >=10cm×10cm，total burn area ≤50% TBSA.
2. Within 96 hours after burns and could be managed within 24 hours after included.
3. Ages from 18 to 60.
4. No serious breathing, circulation and other systemic diseases, no surgical contraindications.
5. Agrees to participate in this trial and has signed an informed consent form.

Exclusion Criteria:

1. Have severe inhalation injury or shock, or acute respiratory failure；
2. There are serious heart (especially the recent myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease;
3. Susceptible to allergies；
4. Islamic believers
5. Pregnant women
6. Other cases that are not suitable for study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dressing change group; Routine dressing change group	Procedure: Routine dressing change; Through regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound. In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing. This technique is widely used in clinic.
Experimental: Dermal matrix dressing group; Limited debridement & Acellular dermal matrix dressing group.	Procedure: Limited debridement & Acellular dermal matrix dressing; In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement. After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair.
Experimental: Epidermal cell spraying group; Limited debridement & Epidermal cell spraying group	Procedure: Limited debridement & Epidermal cell spraying; In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds. The recipient site is 40-80 times than the donor site.
Experimental: BFGF group; Limited debridement & Basic fibroblast growth factor group	Procedure: Limited debridement & Basic fibroblast growth factor; In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells. Studies have shown that bFGF could significantly improve the healing of burn wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing time	Healing time is the number of days when the wound healed completely after management.	21 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing rate	Wound healing rate =（area before management - area after management）/ area before management×100%.	21 days after treatment
Scar formation	Vancouver scar score	6 months after treatment

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Xiangya Hospital of Central South University; Southwest Hospital, China; Second Affiliated Hospital, School of Medicine, Zhejiang University; Ruijin Hospital; Beijing Jishuitan Hospital; First Hospitals affiliated to the China PLA General Hospital
• Investigators: Principal Investigator: Xie Songtao, Doctor, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: KY20140709-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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