Clinical trial NCT06349733: Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"
Official title: Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Scar
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 groups:1 U,2.5 U,5 U, and the control group was injected with 0.9% Nacl.Follow-up was performed immediately after surgery,7 days,15 days,1,3, and 6 months. Follow-up was performed according to SBSES, pruritus, pain, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

Patients with emergency trauma and skin swellings, with clear consciousness, no mental retardation or cognitive difficulties, agree to participate in this study, 12≤ age ≤ 65 years old

Exclusion Criteria:

1. Allergic to botulinum toxin type A;
2. Pregnant, lactating women, patients who plan to get pregnant in the near future;
3. Patients taking retinoic acid, synthetic steroids, amino glycosides antibiotics, calcium channel blockers, cyclosporine and cholinesterase inhibitors; 4 Neuromuscular diseases: such as myasthenia gravis, Lambert-Eaton syndrome, multiple sclerosis;

5. Patients with cardiovascular diseases, kidney diseases, liver and other basic diseases; 6 Patients with infection at the injection site; 7 Expect unrealistic patients.

Primary outcomes:
measure: The modified Stony Brook Scar Evaluation Scale
timeFrame: Postoperative 7 days, 15 days, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Postoperative 7 days, 15 days, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Dezhou
country: China
facility: Qilu Hospital of Shandong University Dezhou Hospital
state: Shandong
Study officials:
References: