A Dosage-dependent Manner of Botulinum Toxin Type A on the Prevention of Postoperative Scars of Various Anatomic Regions of the Body

Shandong University

Status and phase: Completed; Early Phase 1

Conditions: Scar

Treatments: Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT06349733

MR-37-23-008382

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 4 patient groups

Injection 1 U / 0.1ml BTXA

Experimental group

Description:

Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 1U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation.

Treatment:

Drug: Botulinum toxin type A

Injection 2.5U / 0.1ml BTXA

Experimental group

Description:

Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 2.5U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation.

Treatment:

Drug: Botulinum toxin type A

Injection 5U / 0.1ml BTXA

Experimental group

Description:

Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 5U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation.

Treatment:

Drug: Botulinum toxin type A

Injection 0.9%Nacl

Other group

Description:

Immediately after operation 0.9%Nacl was injected on both sides of the knife edge, the injection volume per point was 0.1ml, the interval between each injection point on the same side of the knife edge was 1cm, and each injection point was away from the knife edge 0.5cm. It was injected only once immediately after operation.

Treatment:

Drug: Botulinum toxin type A