Skip to content

The effect of the three-step surgical protocol (TSTK) on treating keloids in the ear: A single-arm study

The effect of the three-step surgical protocol (TSTK) on treating keloids in the ear

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109430
Enrollment
Unknown
Registered
2025-09-18
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Keloid

Interventions

Treatment Group:1. Complete excision of the keloid and fistula in the ear 2. Extensive free reconstruction of subcutaneous tissue structure 3. The ear clip should be used for 6 months after the operat

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 18-60 years old (including limit values) 2. Primary keloid on the ear 3. Skin Fitzpatrick type III/IV 4. No invasive treatments such as glucocorticoid injections or other laser treatments have been administered in the past six months

Exclusion criteria

Exclusion criteria: 1. Patients with multiple keloids involving areas other than the ear 2. Combined with active skin diseases, such as psoriasis, scleroderma, psoriasis, eczema, etc 3. Suffering from endocrine diseases such as diabetes, systemic lupus erythematosus, and systemic sclerosis 4. Systemic diseases with obvious or unstable clinical manifestations are excluded based on the possibility of interfering with the research results. This includes malignant tumors, uncontrollable diabetes, uncontrollable hypertension, unstable pneumonia, organic diseases of the kidneys or liver, unstable myocardial ischemic diseases, dilated myocardial diseases, myocardial conduction disorders or unstable cardiovascular diseases, etc.

Design outcomes

Primary

MeasureTime frame
Recurrence Rate;Satisfaction score for ear morphology;The healing condition of the surgical incision;

Secondary

MeasureTime frame
scar hyperplasia rate;POSAS Scale;

Countries

China

Contacts

Public ContactXiaoLi Wu

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

wuxiaoli528@126.com+86 199 7150 7970

Outcome results

None listed

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