"Outcomes of Surgical Removal of Foreign Body Granulomas"

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

Sponsors

Lead Sponsor: Hospital Angeles del Pedregal

Source 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.

Overall Status Completed
Start Date January 2014
Completion Date November 30, 2020
Primary Completion Date November 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Complications 30 days
Secondary Outcome
Measure Time Frame
Reactivation of symptoms 9 to 76 months
Time for reactivation of symptoms 9 to 76 months
Enrollment 35
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Surgery

Description: (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).

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: Female

Minimum Age: 24 Years

Maximum Age: 64 Years

Location
Facility: Hospital Angeles Pedregal
Location Countries

Mexico

Verification Date

December 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital Angeles del Pedregal

Investigator Full Name: javier lopez

Investigator Title: Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 1

Description: Foreign Substance disseminated to both lower extremities and buttocks

Label: 2

Description: Foreign Substance isolated to buttocks with moderate to severe skin changes

Label: 3

Description: Foreign substance isolated to lower legs with mild skin changes and superficial ulcerations

Label: 4

Description: Foreign substance isolated to lower legs with moderate to severe skin changes and/or ulceration

Patient Data Undecided
Study Design Info

Observational Model: Case-Only

Time Perspective: Retrospective

Source: ClinicalTrials.gov