Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"

NCT ID: NCT06437912

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2024-03-31

Brief Summary

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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

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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 botul

Conditions

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Scar

Keywords

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scar prevention botulinum toxin type A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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 ACTIVE_COMPARATOR

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

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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

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0.9%Nacl

Eligibility Criteria

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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

Allergic to botulinum toxin type A;Pregnant, lactating women, patients who plan to get pregnant in the near future;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

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Dezhou Hospital Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, Shandong, China

Site Status

Countries

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China

Other Identifiers

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MR-37-23-008382

Identifier Type: -

Identifier Source: org_study_id