Outcomes of Surgical Removal of Foreign Body Granulomas

Study Overview
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Brief Summary
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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.

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

Conditions
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Foreign Body Granuloma, Surgery, Complication

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Foreign Substance disseminated to both lower extremities and buttocks | Procedure: Surgery<br>* (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).<br>|
| 2<br>Foreign Substance isolated to buttocks with moderate to severe skin changes | Procedure: Surgery<br>* (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).<br>|
| 3<br>Foreign substance isolated to lower legs with mild skin changes and superficial ulcerations | Procedure: Surgery<br>* (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).<br>|
| 4<br>Foreign substance isolated to lower legs with moderate to severe skin changes and/or ulceration | Procedure: Surgery<br>* (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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Describe if patients have or not postoperative complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactivation of symptoms | Relapse of symptoms or new local complications | 9 to 76 months | 
| Time for reactivation of symptoms | Account the number of months for reactivation of symptoms | 9 to 76 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disease-free, autoimmune/inflammatory syndrome induced by adjuvants (ASIA), adjuvant disease