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Outcomes of Surgical Removal of Foreign Body Granulomas

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04661969
Enrollment
35
Registered
2020-12-10
Start date
2014-01-31
Completion date
2020-11-30
Last updated
2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication, Foreign Body Granuloma, Surgery

Keywords

disease-free, autoimmune/inflammatory syndrome induced by adjuvants (ASIA), adjuvant disease

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.

Interventions

PROCEDURESurgery

(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).

Sponsors

Hospital Angeles del Pedregal
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
24 Years to 64 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Complications30 daysDescribe if patients have or not postoperative complications

Secondary

MeasureTime frameDescription
Reactivation of symptoms9 to 76 monthsRelapse of symptoms or new local complications
Time for reactivation of symptoms9 to 76 monthsAccount the number of months for reactivation of symptoms

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026