Clinical trial NCT04661969: "Outcomes of Surgical Removal of Foreign Body Granulomas"
Official title: "Outcomes of Surgical Removal of Foreign Body Granulomas Due to Polymer Injection for Cosmetic Purposes"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foreign Body Granuloma
Surgery
Complication
Keywords: disease-free
autoimmune/inflammatory syndrome induced by adjuvants (ASIA)
adjuvant disease
Lead sponsor: Hospital Angeles del Pedregal
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 35
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 64
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients previously injected with foreign substances (FS) such as polymers for cosmetic soft tissue augmentation and the diagnosis of ASIA presented with mild to severe skin changes and treated surgically from January 2014 to March 2020 all in a private practice setting (Hospital Angeles Pedregal, Mexico city, MEXICO) and treated all by plastic surgeon senior author (JLM)

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.


Eligibility 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

Primary outcomes:
measure: Complications
timeFrame: 30 days
Secondary outcomes:
measure: Reactivation of symptoms
timeFrame: 9 to 76 months
measure: Time for reactivation of symptoms
timeFrame: 9 to 76 months
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital Angeles Pedregal
state: Cdmx
Study officials:
References: