NCT06550765

Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors

Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors: A Single-Center, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors.

Detailed description

The purpose of this study is to verify and evaluate the safety and effectiveness of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors. The study will be divided into two groups: Experimental Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed. Control Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Electrocautery and suture ligation are used to handle the tumor bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Conditions

• Sarcoma, Soft Tissue
• Sarcoma, Spindle Cell

Interventions

Type	Name	Description
DEVICE	Biodegradable Magnesium Metal Clips	The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Timeline

• Start date: 2024-08-25
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2024-08-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: China