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The efficacy and safety of acupuncture knife combined with implantable suture therapy in the treatment of hypertrophic scars: a randomized controlled trial.

The efficacy and safety of acupuncture knife combined with implantable suture therapy in the treatment of hypertrophic scars: a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002293
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-12-03
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Scar

Interventions

Experimental Group:Acupotomy combined with Catgut Implantation
Control Group:Jieshuai Gel Cream

Sponsors

Chinese Academy of Traditional Chinese Medicine, Xiyuan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meets diagnostic criteria for hypertrophic scars, including: a clear history of trauma, surgery, or burns causing skin damage; localized thickening, redness, and hardness of the scar; often accompanied by symptoms such as itching, pain, heat, and tightness; and boundaries not exceeding the original lesion area. 2. Scar characteristics: located on non-joint areas of the trunk or limbs; area ranging from 25 mm² to 225 cm²; thickness ranging from 0.5 mm to 20 mm; Vancouver Scar Scale (VSS) score of 4 to 12 points; and not formed due to large-scale skin grafting. 3. Age between 18–60 years. 4. Not prone to keloids, with no family history of keloid predisposition. 5. The target scar site is assessed by the investigator as suitable and safe for combined needle knife and (implantable suture) procedures, and both treatment regimens are considered reasonable and acceptable clinical options. 6. Possesses complete clinical information and follow-up records. 7. Signed written informed consent, voluntarily participating and cooperating to complete the study.

Exclusion criteria

Exclusion criteria: 1. Local scar factors: The scar area has infection, rupture, or ulceration, or exhibits characteristics of tumor-like diseases; within a 10 cm² range around the scar site, there are skin diseases (such as eczema, psoriasis), tattoos, or significant unevenness in skin tone that may affect the study results. 2. Specific populations: Pregnant, postpartum, or breastfeeding women. 3. Drug or procedure contraindications: Allergy to the study drug (Sakura Cream), needles, or sutures; presence of contraindications for needle knife/buried suture procedures (e.g., severe coagulation disorders or use of strong anticoagulants/antiplatelet drugs); uncontrolled diabetes (e.g., fasting blood glucose > 7.0 mmol/L), etc. 4. Concurrent systemic diseases: Concurrent autoimmune diseases, organic cardiovascular diseases, severe systemic diseases, or mental disorders; history of organ transplantation or major cardiothoracic surgery, or current use of immunosuppressants or anti-rejection drugs. 5. Recent receipt of other treatments: Receipt of immunosuppressive therapy, dual antiplatelet therapy, glucocorticoids, or other scar treatments (including scar area gua sha or acupuncture, etc., traditional Chinese medical treatments) within the past 1 month, or participation in other clinical trials using the study drug. 6. Investigator judgment: The investigator determines that the patient is only suitable for one treatment option; inability to provide written informed consent, or presence of severe conditions that may affect completion of the study.

Design outcomes

Primary

MeasureTime frame
Vancouver Scar Scale (VSS) Score;

Secondary

MeasureTime frame
Patient and Observer Scar Assessment Scale (POSAS);Scar Thickness;scar area;Dermatology Life Quality Index (DLQI) Questionnaire;

Countries

China

Contacts

Public ContactSong Ping

China Academy of Traditional Chinese Medicine, Xiyuan Hospital

425876377@qq.com18535110903

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026