Venous Malformation treatment

Not yet recruiting

• Conditions: Other specified congenital malformations of peripheral vascular system,

• Registration Number: CTRI/2020/05/025153
• Lead Sponsor: Department of plastic surgery

Brief Summary

All venous malformation patients will be subjected to injection sclerotherapy with Bleomycin and sodium tetra decyl sulphate. Primary efficacy end point of therapy will be reduction in size if any residual malformation evident after treatment it will be surgically excised and reconstructed.

outcome will be assesed based on 5 criterias Color Size,Swelling,cosmetic results and patients opinion. Clinical assesement will be based on 5 point likert system.

at the end of study conclusion will be made regarding which is a better treatment modality for venous malformations.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Last Update Posted: 2020-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Venous Malformation involving soft tissues all over body specifically involving superficial as well as deeper soft tissue.

Exclusion Criteria

Interosseus venous malformation lymphatic malformation hemangiomas high flow venous malformations life threatning venous malformation due to visceral involvement immunosupression chronic infectious disease history of cancer in previous years pregnancy allergy to various sclerosants or lidocaine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary efficacy end point of study will be reduction in size along with color swelling cosmetic results and patient opinion.	3 week 6 week 9 week 12 week 15 week 20 week 24 week 6 month 1 year

Secondary Outcome Measures

Name	Time	Method
assess number of required embolization sessions	3 sweek 6 week 9 week 12 week 15 week 18 week 21 week 24 week
review management strategies and outcomes for our cohort with previous reports	6 months 1 year
complications of sclerosing agents.	3 weeks 6 weeks 9 weeks 12 weeks 12 weeks 15 weeks

Trial Locations

Locations (1)

Department of Plastic surgery; 🇮🇳 Patna, BIHAR, India

Department of Plastic surgery

🇮🇳Patna, BIHAR, India

Ashutosh Shankhdhar

Principal investigator

9455905801

plasticshankhdhar@gmail.com