Foreign Body GranulomaNCT04661969
"Outcomes of Surgical Removal of Foreign Body Granulomas"
An observational study of Foreign Body Granuloma and Surgery, run by Hospital Angeles del Pedregal at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 64 years, women only
- Conditions the study is for
- Foreign Body Granuloma, Surgery, Complication
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2014to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 64 years
- Women only
- Adult
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)
Who may be able to join
- History of injection of foreign substances for cosmetic purposes
- Develop symptoms of Autoimmune syndrome induced by adjuvants
- Mild to severe skin changes
Who cannot join
- Refuse to participate in the analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Outcomes of Surgical Removal of Foreign Body Granulomas Due to Polymer Injection for Cosmetic Purposes"
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
- Being tested
- Surgery
- Keywords
- disease-free, autoimmune/inflammatory syndrome induced by adjuvants (ASIA), adjuvant disease
- Medical subject headings
- Granuloma, Foreign-Body, Arthritis, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or 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).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Foreign Substance disseminated to both lower extremities and buttocks Receives: Procedure: Surgery | |
| 2 | Foreign Substance isolated to buttocks with moderate to severe skin changes Receives: Procedure: Surgery | |
| 3 | Foreign substance isolated to lower legs with mild skin changes and superficial ulcerations Receives: Procedure: Surgery | |
| 4 | Foreign substance isolated to lower legs with moderate to severe skin changes and/or ulceration Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Describe if patients have or not postoperative complications
Measured: 30 days
Secondary outcomes (2)
Reactivation of symptoms
Relapse of symptoms or new local complications
Measured: 9 to 76 months
Time for reactivation of symptoms
Account the number of months for reactivation of symptoms
Measured: 9 to 76 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study startJan 2014
- Primary completionNov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign Body GranulomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Angeles del Pedregal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, javier lopez, Hospital Angeles del Pedregal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661969
- Sponsor's protocol ID
- Polymer removal
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share complications table, kaplan-meier test.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Outcomes of Surgical Removal of Foreign Body Granulomas Due to Polymer Injection for Cosmetic Purposes"
- ClinicalTrials.gov ID
- NCT04661969
- Acronym / sponsor ID
- Polymer removal
- Conditions
- Foreign Body Granuloma, Surgery, Complication
- Keywords
- disease-free, autoimmune/inflammatory syndrome induced by adjuvants (ASIA), adjuvant disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospital Angeles del PedregalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: SurgeryForeign Substance disseminated to both lower extremities and buttocks |
| 2 | – | Procedure: SurgeryForeign Substance isolated to buttocks with moderate to severe skin changes |
| 3 | – | Procedure: SurgeryForeign substance isolated to lower legs with mild skin changes and superficial ulcerations |
| 4 | – | Procedure: SurgeryForeign substance isolated to lower legs with moderate to severe skin changes and/or ulceration |
Who may qualify
- Ages
- 24 to 64 years
- Sex
- Female only
- Age groups
- Adult
- 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)
Key inclusion criteria (3 listed)
- History of injection of foreign substances for cosmetic purposes
- Develop symptoms of Autoimmune syndrome induced by adjuvants
- Mild to severe skin changes
Key exclusion criteria (1 listed)
- Refuse to participate in the analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | 1, 2, 3, 4 |
Primary outcome
Complications
Time frame: 30 days
Describe if patients have or not postoperative complications
2 secondary outcomes
Reactivation of symptoms
Time frame: 9 to 76 months
Time for reactivation of symptoms
Time frame: 9 to 76 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: Undecided. Share complications table, kaplan-meier test.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foreign Body Granuloma and Surgery, run by Hospital Angeles del Pedregal at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.