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A comparative study of a negative pressure closed drainage system and conventional elastic bandage pressure dressing in postoperative incision management of soft tissue tumors of the thighs

A comparative study of a negative pressure closed drainage system and conventional elastic bandage pressure dressing in postoperative incision management of soft tissue tumors of the thighs

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090183
Enrollment
Unknown
Registered
2024-09-25
Start date
2024-09-30
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Soft tissue tumors of the thigh

Interventions

Control group:conventional elastic bandage gauze compression dressing
Experimental group:VSD joint elastic bandage, harmonic scalpel

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the clinical study and sign the informed consent form; 2. aged = 18 years. 3. inclusion of pathologic subtypes including, but not limited to: giant lipoma, liposarcoma, pleomorphic sarcoma, rhabdomyosarcoma, osteosarcoma, chondrosarcoma, giant cell tumor of bone; 4. no prior systemic therapy or 21 days after completion of systemic therapy; 5. ECOG score of 0-1; 6. expected survival = 6 months; 7. Adequate major organ function, defined as: (1) Blood count (no blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor therapy within 14 days prior to the test): white blood cells (WBC) =4.0×10^9/L, absolute neutrophil count (ANC) =1.5×10^9/L, platelet count (PLT) =100×10^9/L Hemoglobin (Hb) =90g/L (not transfused with blood and blood products within 14 days, not corrected with hematopoietic stimulating factor); (2) Liver function: total bilirubin (TBIL) =2.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3×ULN, serum albumin =3.0g/dL (30 g/L); (4) Kidney function (4) Renal function: creatinine clearance (Ccr) = 60 ml/min (Cockcroft-Gault formula); (5) Coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 x ULN; 8. Cardiac and pulmonary function capable of tolerating surgery as assessed by the investigator; 9. be able to tolerate the surgery and bear the costs.

Exclusion criteria

Exclusion criteria: 1. patients in whom R0 resection cannot be obtained; 2. preoperative radiotherapy; 3. advanced or unresectable bone and soft tissue sarcomas with indeterminate pathology or confirmed by histology or cytology; 4. patients with active infectious lesions; 5. patients with myocutaneous flap metastasis.

Design outcomes

Primary

MeasureTime frame
Wound complication rate within 30 days after surgery (large haematoma, delayed and non-healing, necrotic wound dehiscence, infection);

Secondary

MeasureTime frame
Local recurrence rate within 2 years after surgery;MSTS functional score at postoperative month 12;

Countries

China

Contacts

Public ContactZhang Chunlin

Shanghai Tenth People's Hospital

shzhangchunlin123@163.com+86 189 1768 7912

Outcome results

None listed

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