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NCT Number: NCT06349733

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, Shandong, 253000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

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

Other names: 0.9%Nacl

Primary outcomes

  1. The modified Stony Brook Scar Evaluation Scale

    Time frame: Postoperative 7 days, 15 days, 1 month, 3 months, 6 months

    The mSBSES included width (0 = scar enlargement prominent and > 2 mm, 1 = presence of scar enlargement ≤ 2 mm, 2 = no scar widening), height (0 = marked scar uplift, 1 = presence of scar uplift, 2 = no scar uplift), color (0 = scar significantly redder than surrounding, 1 = scar redder than surrounding and 2 = scar the same color as or lighter than surrounding skin), The visibility of the incision line (0 = marked incision line, 1 = presence of incision line, 2 = absence of incision line) was objectively assessed separately in non-chronological order, with overall scar values varying from 0 to 8, with higher scores indicating better scar appearance.

Secondary outcomes

  1. Patient satisfaction

    Time frame: Postoperative 7 days, 15 days, 1 month, 3 months, 6 months

    Patient satisfaction was measured on a four-point scale, with 1 = dissatisfied,2 = somewhat satisfied,3 = satisfied, and 4 = very satisfied.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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