Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170008
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-06-04
Brief Title:
Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 woundsThe 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
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
Detailed Description:
In this study a single-centre autologous petrolatum gauze or decellularised pig skin treatment was used to study the effect of physical microstructure-modified transparent silicone membranes on the repair of second-degree burn wounds and implant-area wounds in a parallel controlled study using a randomised controlled clinical trial In this study 40 patients were enrolled in the burn surgery department of the First Affiliated Hospital of the Naval Military Medical University with 20 second-degree burn wounds and 20 implant-area wounds each The same patients were divided into a conventional treatment group second-degree burn wounds covered with decellularized pig skin and implant-area wounds covered with petroleum jelly gauze and a silicone film-covered group according to the computerized random number method After routine clinical treatment of the wounds the wounds were covered with the corresponding dressings according to the groups and the healing rate transparency of the dressings adhesion of the dressings to the wounds pain level of the patients when the dressings were removed infection rate of the wounds and incidence of adverse reactions were observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None