"Outcomes of Surgical Removal of Foreign Body Granulomas"

NCT04661969 | Completed

• 1 other identifier: Polymer removal
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Foreign Body Granuloma; Surgery; Complication

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complications

  Describe if patients have or not postoperative complications

  30 days

Secondary Outcomes (2)

• Reactivation of symptoms

  9 to 76 months

• Time for reactivation of symptoms

  9 to 76 months

Study Arms (4)

1

Foreign Substance disseminated to both lower extremities and buttocks

Procedure: Surgery

2

Foreign Substance isolated to buttocks with moderate to severe skin changes

Procedure: Surgery

3

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

Procedure: Surgery

4

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

Procedure: Surgery

Interventions

Surgery PROCEDURE

(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).

1; 2; 3; 4

Eligibility Criteria

• Age: 24 Years - 64 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• History of injection of foreign substances for cosmetic purposes
• Develop symptoms of Autoimmune syndrome induced by adjuvants
• Mild to severe skin changes

You may not qualify if:

• Refuse to participate in the analysis

Sponsors & Collaborators

• Hospital Angeles del Pedregal: lead

Study Sites (1)

Hospital Angeles Pedregal

Mexico City, Mexico City, 01330, Mexico

Location

MeSH Terms

Conditions

Granuloma, Foreign-Body; Arthritis, Experimental

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign-Body Reaction; Foreign Bodies; Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: January 1, 2014
• Primary Completion: November 1, 2020
• Study Completion: November 30, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

ME (1)