An observational study in Foreign Body Granuloma, Surgery and Complication, sponsored by Hospital Angeles del Pedregal. Completed at 1 site in Mexico. Open to female participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by Hospital Angeles del Pedregal · Observational
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.
Hospital Angeles del Pedregal is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Foreign Substance disseminated to both lower extremities and buttocks
Procedure: Surgery
Foreign Substance isolated to buttocks with moderate to severe skin changes
Procedure: Surgery
Foreign substance isolated to lower legs with mild skin changes and superficial ulcerations
Procedure: Surgery
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).
Complications
Describe if patients have or not postoperative complications
Time frame: 30 days
Reactivation of symptoms
Relapse of symptoms or new local complications
Time frame: 9 to 76 months
Time for reactivation of symptoms
Account the number of months for reactivation of symptoms
Time frame: 9 to 76 months
Plan to share: Undecided — Share complications table, kaplan-meier test.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Granuloma, Foreign-Body
Hospital Angeles del Pedregal