## Protocol Section
### Identification Module
**NCT ID:** NCT06437912

**Brief Title:** Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"

**Official Title:** Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal

#### Organization Study ID Info
**ID:** MR-37-23-008382
#### Organization
**Class:** OTHER
**Full Name:** Dezhou Hospital Qilu Hospital of Shandong University
### Status Module
#### Completion Date
**Date:** 2024-03-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-10-10

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dezhou Hospital Qilu Hospital of Shandong University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 botul

### Conditions Module

**Conditions:**

- Scar

**Keywords:**

- scar prevention

- botulinum toxin type A

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Drug: Botulinum toxin type A

**Label:** Injection 1 U / 0.1ml BTXA

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Drug: Botulinum toxin type A

**Label:** Injection 2.5U / 0.1ml BTXA

**Type:** EXPERIMENTAL

#### Arm Group 3

**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.

**Intervention Names:**

- Drug: Botulinum toxin type A

**Label:** Injection 5U / 0.1ml BTXA

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 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.

**Intervention Names:**

- Drug: Botulinum toxin type A

**Label:** Injection 0.9%Nacl

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Injection 0.9%Nacl

- Injection 1 U / 0.1ml BTXA

- Injection 2.5U / 0.1ml BTXA

- Injection 5U / 0.1ml BTXA

**Description:** 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

**Name:** Botulinum toxin type A

**Other Names:**

- 0.9%Nacl

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** The modified Stony Brook Scar Evaluation Scale

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

#### Secondary Outcomes

**Description:** Patient Satisfaction Scale (1=dissatisfied, 2=slightly satisfied, 3=satisfied, and 4=very satisfied). They were also asked to assess their levels of pain (0=no pain, 1=mild, 2=moderate, 3=severe, 4=very painful) and pruritus (0=no itch, 1=mild, 2=moderate, 3=severe, 4=very itchy) at the incision site. The totals varied between 0-8, where lower scores indicated more positive subjective patient perceptions.

**Measure:** Patient satisfaction and perceptions represented secondary outcome measures in this study

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

### Eligibility Module

**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:

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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dezhou

**Country:** China

**Facility:** Qilu Hospital of Shandong University Dezhou Hospital

**State:** Shandong

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005355

- Term: Fibrosis

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6160

- Name: Cicatrix

- Relevance: HIGH

- As Found: Scar

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002921

- Term: Cicatrix

### Intervention Browse Module - Ancestors

- ID: D000065087

- Term: Acetylcholine Release Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M5183

- Name: Botulinum Toxins

- Relevance: HIGH

- As Found: Light

- ID: M21257

- Name: Botulinum Toxins, Type A

- Relevance: HIGH

- As Found: Pregnant

- ID: M250193

- Name: abobotulinumtoxinA

- Relevance: HIGH

- As Found: Pregnant

- ID: M3473

- Name: Acetylcholine

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001905

- Term: Botulinum Toxins

- ID: D000019274

- Term: Botulinum Toxins, Type A

- ID: C000542869

- Term: abobotulinumtoxinA

### Misc Info Module

- Version Holder: 2024-05-31
