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HyaluronicAcid for skin and soft tissue tumour boundary localisation:a randomised half side controlled trial

HyaluronicAcid for skin and soft tissue tumour boundary localisation:a randomised half side controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096544
Enrollment
Unknown
Registered
2025-01-26
Start date
2025-01-27
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Skin and soft tissue tumour

Interventions

Experimental group:Mix sodium hyaluronate gel for injection and methylene blue for injection 1 to 1. The PI will use a 2 ml syringe and a 27G*14mm needle to inject into the dermis at the marked tumour
Control group:Conventional approach: depiction of tumour boundaries visible to the naked eye with a marker pen.

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients with malignant tumours of the soft tissues of the skin, with the type of tumour including but not limited to, basal cell carcinoma, squamous cell carcinoma, malignant melanoma, fibrosarcoma, liposarcoma, and hemangiosarcoma, attending the First Medical Center of the Chinese PLA General Hospital; (2) The patient is at least 18 years old; (3) There are biopsy pathology results for clear diagnosis; (4) There are indications for surgery; (5) Patients who agree to participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who do not have indications for surgery; (2) Patients who are under 18 years old, pregnant or breastfeeding; (3) Allergic to hyaluronic acid or methylene blue; (4) Infection at the proposed injection site; (5) Patients who refuse to participate.

Design outcomes

Primary

MeasureTime frame
Distance between the tumor's pathological border and the edge of the surgical incision, and the area of healthy tissue between them;Repair Modality;

Secondary

MeasureTime frame
Complications;Cost;Surgical Time;Postoperative Patient-Reported Outcome Scores(FACE-Q);

Countries

China

Contacts

Public ContactYoubai Chen

No.28, Fuxing Road, Haidian District, Beijing City

chenyoubai@301hospital.com.cn+86 151 1026 4464

Outcome results

None listed

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