"Outcomes of Surgical Removal of Foreign Body Granulomas"

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Complication; Foreign Body Granuloma
• Intervention / Treatment: Procedure: Surgery

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Mexico
  • Cdmx
    • Mexico city, Cdmx, Mexico, 01330
      • Hospital Angeles Pedregal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 64 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Foreign Substance disseminated to both lower extremities and buttocks	Procedure: Surgery; (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).
2; Foreign Substance isolated to buttocks with moderate to severe skin changes	Procedure: Surgery; (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).
3; Foreign substance isolated to lower legs with mild skin changes and superficial ulcerations	Procedure: Surgery; (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).
4; Foreign substance isolated to lower legs with moderate to severe skin changes and/or ulceration	Procedure: Surgery; (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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Angeles del Pedregal

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: disease-free; autoimmune/inflammatory syndrome induced by adjuvants (ASIA); adjuvant disease
• Additional Relevant MeSH Terms: Pathologic Processes; Lymphoproliferative Disorders; Lymphatic Diseases; Wounds and Injuries; Foreign-Body Reaction; Granuloma; Foreign Bodies; Granuloma, Foreign-Body
• Other Study ID Numbers: Polymer removal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Share complications table, kaplan-meier test.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No