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OpenTrials
Completed

NCT Number: NCT04661969

"Outcomes of Surgical Removal of Foreign Body Granulomas"

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Complications

    Time frame: 30 days

    Describe if patients have or not postoperative complications

Secondary outcomes

  1. Reactivation of symptoms

    Time frame: 9 to 76 months

    Relapse of symptoms or new local complications

  2. Time for reactivation of symptoms

    Time frame: 9 to 76 months

    Account the number of months for reactivation of symptoms

Sponsors and collaborators

Lead sponsor

Hospital Angeles del Pedregal

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2020
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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