Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds

NCT06170008 | Not Yet Recruiting DMC

• 1 other identifier: chhaodylan
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to comparison of physical microstructure-modified transparent silicone films and current conventional trauma dressings for second-degree burn wounds and post-skin graft wounds.The main question it aims to answer is : The development of a new type of wound dressing is urgently needed because existing wound dressings cannot be transparent, easy to change, easy to store and inexpensive at the same time. Participants will receive routine wound treatment, after which they will be covered with a clear silicone membrane with physical microstructure modification. Researchers will compare vaseline gauze group and decellularised pigskin group o see if transparent silicone film with physical microstructure modifications promotes wound healing, reduces the number of dressing changes, reduces the damage to the wound and painful irritation to the patient during dressing changes, thus improving the quality of wound repair and saving medical costs.

Conditions

Second-degree Burn Wounds; Skin Graft Wounds

Keywords

Second-degree burn wounds; skin graft wounds; Wound coverings

Outcome Measures

Primary Outcomes (2)

• Wound healing time

  Change the dressing at one-day intervals after the application of trauma coverings, observe the trauma, and record the healing time when the trauma is 90% healed. The wound healing rate is: healed wound area / original wound area. There are two methods to calculate the healed area: A, visual method: visual assessment; B, image analysis method: vertical trauma surface is photographed under natural light (20CM and 40CM respectively), and the computer analyzes the trauma healing rate. The image analysis method shall prevail, and the image method shall prevail in case of inconsistent results.

  one day interval after wound coverage application

• Wound healing rate

  The wound healing rate was calculated on the 14th days after the treatment. The wound healing rate was calculated as: healed wound area/ original wound area. There are two methods for calculating the healed area: A, visual method: visual assessment; B, image analysis method: vertical trauma surface is photographed under natural light (20CM and 40CM distance respectively) and the computer analyzes the trauma healing rate. The image analysis method shall prevail, and the image method shall prevail in case of inconsistent results.

  14th days after the treatment

Secondary Outcomes (5)

• Transparency

  7th, 14th, 21st and 28th days after the treatment

• Adhesions and pain

  7th, 14th, 21st and 28th days after the treatment

• Number of inner layer dressing changes

  Within four weeks of treatment

• Infection rate

  7th, 14th, 21st and 28th days after the treatment

• Incidence of adverse reactions

  7th, 14th, 21st and 28th days after the treatment

Study Arms (4)

Second-degree burn wounds covered with silicone film sheet group

EXPERIMENTAL

After routine clinical treatment of second-degree burn wounds, the innermost layer is covered with physical microstructure-modified transparent silicone film sheet , and the outer dressing is changed every 3 to 4 days to observe and record the wounds, and the innermost dressing is changed weekly or as necessary and the number of times is recorded to observe the wound healing rate, dressing transparency, dressing-wound adhesion, pain level, wound infection rate and incidence of adverse reactions.

Device: Physical microstructure-modified transparent silicone film sheet

Second-degree burn wounds covered with decellularized pig skin group

ACTIVE COMPARATOR

After routine clinical treatment of second-degree burn wounds, the innermost layer was covered with decellularized pig skin, the outer dressing was changed every 3 to 4 days, the wounds were observed and recorded, and the innermost dressing was changed weekly or as necessary and the number of times was recorded to observe the wound healing rate, dressing transparency, dressing-wound adhesion, pain level, wound infection rate and incidence of adverse reactions.

Device: Decellularized pig skin

Post-operative skin grafting wounds covered with silicone film sheet group

EXPERIMENTAL

After skin grafting, the innermost layer is covered with physical microstructure-modified transparent silicone film sheet , and the outer dressing is changed every 3 to 4 days to observe and record the wound. The innermost layer is changed weekly or as necessary and the number of times is recorded to observe the wound healing rate, transparency of the dressing, adhesion of the dressing to the wound, pain, wound infection rate and incidence of adverse reactions.

Device: Physical microstructure-modified transparent silicone film sheet

Post-operative skin grafting wounds covered with vaseline gauze group

ACTIVE COMPARATOR

After skin grafting, the innermost layer was covered with vaseline gauze, and the outer layer was changed every 3 to 4 days to observe and record the wound. The innermost layer was changed weekly or as necessary and the number of times was recorded to observe the wound healing rate, transparency of the dressing, adhesion of the dressing to the wound, pain, wound infection rate and incidence of adverse reactions.

Device: Vaseline gauze

Interventions

Physical microstructure-modified transparent silicone film sheet DEVICE

The main component of the physical microstructure-modified transparent silicone film sheet is transparent silicone rubber, which has a three-dimensional microstructure on its trauma contact surface through physical mechanics treatment, which can provide effective mechanical stimulation for trauma healing. And after testing, the silicone film sheet is breathable, light-permeable, non-toxic and non-allergenic. It is expected to significantly reduce the number of dressing changes, reduce the damage to the wound and the painful stimulation to the patient during dressing changes, and promote the healing of the wound to a certain extent, thus improving the quality of wound repair and saving medical costs.

Post-operative skin grafting wounds covered with silicone film sheet group; Second-degree burn wounds covered with silicone film sheet group

Decellularized pig skin DEVICE

Decellularized pig skin is an allogeneic trauma covering from pigs and is a commonly used trauma covering for second-degree burn wounds. It adheres to clean superficial wounds, creates a temporary barrier to the wound, reduces wound exudation, limits loss of body components, improves microcirculatory stasis, provides a microenvironment suitable for wound healing, protects inter-ecological tissue, promotes repair and regeneration, and reduces pain. Its disadvantages are: soft structure, difficult to fix the trauma; opaque, unable to observe the trauma; pigskin needs to be stored under suitable temperature and humidity, and has a limited time. When used, decellularized pig skin is directly covered on conventionally treated second-degree burn wounds.

Second-degree burn wounds covered with decellularized pig skin group

Vaseline gauze DEVICE

Vaseline gauze is the most commonly used conventional dressing for the implant area, which is mainly made of skimmed cotton gauze impregnated with petroleum jelly and paraffin oil, which has a lubricating effect and can promote the growth of granulation and wound healing. However, its moisturizing time is relatively short and requires frequent dressing changes; moreover, petroleum jelly gauze often adheres to the wound surface severely, which may cause bleeding and new epidermal damage during dressing changes and affect the wound healing; the wound surface is constantly oozing blood and fluid, and the dressing cannot be effectively isolated from the outside world after wetting, which increases the chance of infection. Vaseline gauze is applied directly to the post-operative skin grafting wound.

Post-operative skin grafting wounds covered with vaseline gauze group

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12 to 70 years, regardless of gender;
• Second-degree burns with an area greater than 1% TBSA and a single observable trauma area ≥ 10 cm × 10 cm(jointly determined by two burn specialists with the title of attending physician or above according to the four degrees and five points method);
• Voluntary signed informed consent form

You may not qualify if:

• Patients during pregnancy;
• Significant cardiac, pulmonary and renal insufficiency;
• Critically ill or with serious complications such as severe sepsis or MODS;
• Positive for HBV, HCV, HIV or syphilis;
• Traumatic surface infection;
• Involving the face, hands, groin, joints, feet and other areas difficult to bandage and fix; previous burn trauma treatment; previous burns on the same site; electrical burns; patients with inhalation injuries.
• Known sensitivity or allergy to one of the dressings or its components; diabetes mellitus; presence of immune system disorders or long-term hormone or immunotherapy
• Others who, in the opinion of the investigator, are not suitable for enrollment.

Sponsors & Collaborators

• Changhai Hospital: lead

Central Study Contacts

Shichu Xiao, PhD

CONTACT

+86 13166379405; huangzhuoxiao@sohu.com

Hao Chen, Master

CONTACT

+86 15666681906; chhaodylan@163.com

Study Design

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

Model Details: The second-degree burn wounds were covered with clear silicone film and decellularized pig skin after conventional clinical treatment. After skin grafting, the wounds were covered with transparent silicone film and petroleum jelly gauze with physical microstructure modification.

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: December 14, 2023
• Study Start: December 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12