Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-27
Brief Title:
Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of Optimal Concentration
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of Optimal Concentration
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
Each year millions of burn trauma or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning In order to prevent and treat diseases related to abnormal scar hyperplasia clinicians and researchers have adopted various methods such as scar grinding surgical resection drug injection in scar tissue cryotherapy laser and so on However these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients To date there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue
Detailed Description:
Through a large number of literature review and preliminary experiments we summarized and found the following problems a The latest research on prevention of scar formation by botulinum toxin type A is only aimed at surgical wounds from the wound type and there is no research on the scar prevention effect of trauma wounds b From the point of view of the study site there is no study on the effect of scar prevention only on the head neck chest and other parts of the body c For the research results of botulinum toxin type A in the prevention of scarring the current research focuses on the effectiveness of botulinum toxin type A at a certain concentration and does not compare the effects of botulinum toxin type A at various concentrations
Therefore in order to explore the optimal concentration of botulinum toxin type A to prevent scar formation To explore the effect of botulinum toxin A on scar prevention of traumatic wounds and surgical incisions To explore the effect of botulinum toxin A on scar prevention in other parts of the body in addition to effective prevention of head neck and chest scar We intend to focus on the effectiveness and optimal concentration of botulinum toxin type A to prevent scarring to determine the effect of this means on scar prevention to provide new ideas for botulinum toxin type A to prevent scarring and to broaden the methods of scar prevention
Patients were randomly assigned to experimental group and control group The experimental group was treated according to botulinum toxin type A The concentration gradient of toxin was set to 3 groups1 U25 U5 U and the control group was injected with 09 NaclFollow-up was performed immediately after surgery7 days15 days13 and 6 months Follow-up was performed according to SBSES pruritus pain and patient satisfaction
Therefore in order to explore the optimal concentration of botulinum toxin type A to prevent scar formation To explore the effect of botulinum toxin A on scar prevention of traumatic wounds and surgical incisions To explore the effect of botulinum toxin A on scar prevention in other parts of the body in addition to effective prevention of head neck and chest scar We intend to focus on the effectiveness and optimal concentration of botulinum toxin type A to prevent scarring to determine the effect of this means on scar prevention to provide new ideas for botulinum toxin type A to prevent scarring and to broaden the methods of scar prevention
Patients were randomly assigned to experimental group and control group The experimental group was treated according to botulinum toxin type A The concentration gradient of toxin was set to 3 groups1 U25 U5 U and the control group was injected with 09 NaclFollow-up was performed immediately after surgery7 days15 days13 and 6 months Follow-up was performed according to SBSES pruritus pain and patient satisfaction
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