"Outcomes of Surgical Removal of Foreign Body Granulomas"

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661969
• Other study ID #: Polymer removal
• Status: Completed
• Start date: January 2014
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Hospital Angeles del Pedregal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 30, 2020
• Est. primary completion date: November 2020
• Gender: Female
• Age group: 24 Years to 64 Years

Eligibility

Inclusion Criteria:

• History of injection of foreign substances for cosmetic purposes

• Develop symptoms of Autoimmune syndrome induced by adjuvants

• Mild to severe skin changes

Exclusion Criteria:

• Refuse to participate in the analysis

Related Conditions & MeSH terms

• Complication
• Foreign Bodies
• Foreign Body Granuloma
• Granuloma
• Granuloma, Foreign-Body
• Surgery

Intervention

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).

Locations

Country	Name	City	State
Mexico	Hospital Angeles Pedregal	Mexico city	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Angeles del Pedregal

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Describe if patients have or not postoperative complications	30 days
Secondary	Reactivation of symptoms	Relapse of symptoms or new local complications	9 to 76 months
Secondary	Time for reactivation of symptoms	Account the number of months for reactivation of symptoms	9 to 76 months