NCT04661969

"Outcomes of Surgical Removal of Foreign Body Granulomas"

"Outcomes of Surgical Removal of Foreign Body Granulomas Due to Polymer Injection for Cosmetic Purposes"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Hospital Angeles del Pedregal · Academic / Other
• Sex: Female
• Age: 24 Years – 64 Years
• Healthy volunteers: —

Summary

Illicit subcutaneous injection of high-viscosity fluids for restoration and improvement of body contour is a growing trend all around the world. Many local and systemic complications have been described. Local complications include deformity at the site of injection, granulomas and several skin changes like erythema, induration, and plaques (well-circumscribed, elevated, superficial, solid lesion). The investigator designed a single-center, cross-sectional, retrospective, consecutive case series study and evaluated 49 surgeries performed in 35 patients with the history of foreign substances injection for cosmetic purposes and developed local complications. Investigators divided 4 groups accordingly to localization of foreign substances (FS). Group 1) FS disseminated to both lower extremities and buttocks; group 2) FS isolated to buttocks with moderate to severe skin changes, Group 3) FS isolated to lower legs with mild skin changes and superficial ulcerations and 4) FS isolated to lower legs with moderate to severe skin changes and/or ulceration. The investigators treated all patients surgically, which consisted of isolate ultrasonic liposuction for extraction of the material from the affected region (group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4). Statistical analysis was performed to find relations between type of surgery with complications, reactivation of symptoms, time for reactivation and a disease-free survival test (kaplan meier) was done.

Conditions

• Foreign Body Granuloma
• Surgery
• Complication

Interventions

Type	Name	Description
PROCEDURE	Surgery	(group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4).

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-11-01
• Completion: 2020-11-30
• First posted: 2020-12-10
• Last updated: 2020-12-11

Locations

1 site across 1 country: Mexico