"Outcomes of Surgical Removal of Foreign Body Granulomas"

Hospital Angeles Pedregal

Status: Completed

Conditions: Complication; Surgery; Foreign Body Granuloma

Treatments: Procedure: Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04661969

Polymer removal

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Female

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 4 patient groups

1

Description:

Foreign Substance disseminated to both lower extremities and buttocks

Treatment:

Procedure: Surgery

2

Description:

Foreign Substance isolated to buttocks with moderate to severe skin changes

Treatment:

Procedure: Surgery

3

Description:

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

Treatment:

Procedure: Surgery

4

Description:

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

Treatment:

Procedure: Surgery