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"Outcomes of Surgical Removal of Foreign Body Granulomas"

NCT ID: NCT04661969

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Foreign Body Granuloma Surgery Complication

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Foreign Substance disseminated to both lower extremities and buttocks

Surgery

Intervention Type 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).

2

Foreign Substance isolated to buttocks with moderate to severe skin changes

Surgery

Intervention Type 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).

3

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

Surgery

Intervention Type 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).

4

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

Surgery

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Angeles del Pedregal

OTHER

Sponsor Role lead

Responsible Party

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javier lopez

Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Angeles Pedregal

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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Polymer removal

Identifier Type: -

Identifier Source: org_study_id