Completed

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

What is being tested

Botulinum toxin type A

Drug

Who is being recruted

Cicatrix+1

+ Fibrosis

+ Pathologic Processes

From 12 to 65 Years

See all eligibility criteria

How is the trial designed

Prevention Study

Early Phase 1

Interventional

Study Start: March 2023

See protocol details

Summary

Principal SponsorQilu Hospital of Shandong University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 23, 2023

Actual date on which the first participant was enrolled.

This study aims to find the best concentration of botulinum toxin type A for preventing scar formation, especially on different parts of the body like the head, neck, and chest, and in various types of wounds including traumatic and surgical wounds. Currently, research mainly focuses on surgical wounds and does not explore various concentrations of the toxin. By understanding how different concentrations work, this study could lead to more effective ways to prevent scars, which can improve healing and appearance after injuries or surgeries. Participants in the study are divided into two groups. One group receives different concentrations of botulinum toxin type A, while the other receives a saline solution as a control. The concentrations used in the study are 1 unit, 2.5 units, and 5 units. Researchers follow up with participants immediately after treatment and then at multiple times over six months to assess scar prevention effectiveness. They evaluate outcomes using criteria such as scar appearance, itchiness, pain, and patient satisfaction. This approach helps determine both the effectiveness and any potential side effects of the treatment.

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

NCT06349733

Principal SponsorQilu Hospital of Shandong University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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 II

Experimental

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 III

Experimental

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 IV

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, ChinaOpen Qilu Hospital of Shandong University Dezhou Hospital in Google Maps

CompletedOne Study Center