"Outcomes of Surgical Removal of Foreign Body Granulomas"

Completed

• Conditions: Surgery; Complication; Foreign Body Granuloma
• Interventions: Procedure: Surgery

• Registration Number: NCT04661969
• Lead Sponsor: Hospital Angeles del Pedregal

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2020-11
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-09
• Study First Posted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Surgery	Foreign Substance isolated to buttocks with moderate to severe skin changes
4	Surgery	Foreign substance isolated to lower legs with moderate to severe skin changes and/or ulceration
1	Surgery	Foreign Substance disseminated to both lower extremities and buttocks
3	Surgery	Foreign substance isolated to lower legs with mild skin changes and superficial ulcerations

Primary Outcome Measures

Name	Time	Method
Complications	30 days	Describe if patients have or not postoperative complications

Secondary Outcome Measures

Name	Time	Method
Reactivation of symptoms	9 to 76 months	Relapse of symptoms or new local complications
Time for reactivation of symptoms	9 to 76 months	Account the number of months for reactivation of symptoms

Trial Locations

Locations (1)

Hospital Angeles Pedregal; 🇲🇽 Mexico city, Cdmx, Mexico