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

NCT ID: NCT06349733

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2024-03-30

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.

Conditions

Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Injection 1 U / 0.1ml BTXA

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.

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl

Injection 2.5U / 0.1ml BTXA

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.

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl

Injection 5U / 0.1ml BTXA

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.

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl

Injection 0.9%Nacl

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.

Group Type: OTHER

Botulinum toxin type A

Intervention Type: DRUG

Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl

Interventions

Botulinum toxin type A

Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl

Intervention Type: DRUG

Other Intervention Names

0.9%Nacl

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, Shandong, China

Countries

China

Other Identifiers

MR-37-23-008382

Identifier Type: -

Identifier Source: org_study_id