Soft Tissue Filler ComplicationNCT07808957
Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal
A study testing Indocyanine Green and Standard Clinical Perfusion Assessment in people with Soft Tissue Filler Complication and Surgical Flap Ischemia, run by Research Inc at 1 site in Colombia.
Trial summary
This randomized clinical trial will compare indocyanine green fluorescence angiography-guided assessment with standard clinical assessment of gluteal flap perfusion during removal of permanent synthetic fillers. Participants will be assigned 1:1 to fluorescence-guided or standard management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Filler Complication, Surgical Flap Ischemia, Tissue Necrosis
- What is being tested?
- Indocyanine Green and Standard Clinical Perfusion Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Scheduled for elective gluteal permanent synthetic filler removal with flap elevation and primary closure.
- Expected availability of the study fluorescence imaging system.
- Ability to provide written informed consent and complete 90-day wound follow-up.
Who cannot join
- Known hypersensitivity to indocyanine green.
- Pregnancy or breastfeeding.
- Emergency surgery, uncontrolled sepsis, or hemodynamic instability at the time of randomization.
- Severe hepatic dysfunction or another condition judged by anesthesia to make indocyanine green inappropriate.
- Prior enrollment in this trial for a contralateral or repeat operation.
- Inability to undergo standardized postoperative wound assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Clinica Bioforma
Medellín
Edison Osorio, MD, Plastic surgeon, +573226140611, info@edisonosorio.com
About this study
This randomized clinical trial will compare indocyanine green fluorescence angiography-guided assessment with standard clinical assessment of gluteal flap perfusion during removal of permanent synthetic fillers. Participants will be assigned 1:1 to fluorescence-guided or standard management. The primary outcome is the occurrence of flap ischemia, ischemia-related wound dehiscence, or tissue necrosis through postoperative day 30. Dye-related adverse reactions, management changes, wound healing, infection, and reoperation will also be evaluated.
Read the detailed description
Adults undergoing gluteal filler-removal surgery with flap elevation will be randomized before definitive flap assessment. In both groups, the surgeon will record the planned closure after routine clinical evaluation. In the intervention group, intravenous indocyanine green and a standardized near-infrared imaging protocol will then be used to identify hypoperfused tissue. Management changes will follow a locked decision algorithm. The control group will proceed using clinical assessment alone. Postoperative wounds will be evaluated by assessors masked to allocation using standardized definitions and photographs through day 90. The trial will compare the 30-day composite ischemic complication rate and will evaluate necrosis, dehiscence, reoperation, time to healing, ICG-related reactions, and quantitative perfusion metrics.
- Being tested
- Indocyanine Green, Standard Clinical Perfusion Assessment
- Keywords
- Indocyanine Green, Fluorescence Angiography, Perfusion Imaging, Gluteal Flap, Wound Dehiscence, Tissue Necrosis, Biopolymers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
PROPOSED regimen: 0.05 mg/kg intravenously followed by a saline flush after flap preparation and before definitive closure; one repeat dose may be used if the image is technically inadequate, within the approved local labeling and maximum dose. Final product, concentration, and dose must be confirmed. Linked arm/group(s): ICG-Guided Perfusion Assessment.
Standard Clinical Perfusion AssessmentProcedure or surgery
Surgeon assessment based on tissue color, capillary refill, dermal bleeding, temperature, and clinical judgment. This procedure is used in both groups; the control group does not receive fluorescence imaging. Linked arm/group(s): ICG-Guided Perfusion Assessment, Standard Clinical Perfusion Assessment.
| Study group | Role | What they receive |
|---|---|---|
| ICG-Guided Perfusion Assessment (Experimental) | Experimental | Standard clinical assessment plus intraoperative indocyanine green fluorescence angiography. Hypoperfused regions may prompt additional excision, release of tension, or modification of closure according to the locked decision algorithm. Receives: Drug: Indocyanine Green; Procedure: Standard Clinical Perfusion Assessment |
| Standard Clinical Perfusion Assessment (Active Comparator) | Active comparator | Flap perfusion is assessed using routine clinical criteria without fluorescence imaging. All other perioperative care follows the same institutional protocol. Receives: Procedure: Standard Clinical Perfusion Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ischemic Gluteal Flap Complications
Proportion of participants with at least one adjudicated event: clinically significant flap ischemia requiring treatment, ischemia-related wound dehiscence, partial-thickness necrosis, or full-thickness necrosis. A masked committee will apply prespecified definitions using clinical records and standardized photographs.
Measured: From surgery through postoperative day 30. 30 days
Secondary outcomes (5)
Incidence of Partial- or Full-Thickness Flap Necrosis
Proportion of participants with adjudicated tissue necrosis, reported separately as partial- and full-thickness and by surface area category.
Measured: From surgery through postoperative day 30. 30 days
Intraoperative Change in Surgical Management
Proportion of intervention participants in whom ICG imaging causes additional tissue excision, release of closure tension, change in flap design, delay in closure, or another documented management modification compared with the plan recorded immediately before imaging.
Measured: From surgery through postoperative day 30. 30days
Time to Complete Wound Healing
Number of days from surgery to complete epithelialization without drainage or dressing requirement, censored at 90 days.
Measured: From surgery through postoperative day 90. 90 days
Incidence of Indocyanine Green-Related Adverse Reactions
Proportion of intervention participants with hypersensitivity, urticaria, hemodynamic reaction, bronchospasm, or other adverse event judged related to indocyanine green.
Measured: From indocyanine green administration through 24 hours after surgery. 1 day
Incidence of Reoperation for Wound Complications
Proportion of participants requiring operative debridement, revision closure, grafting, or flap reconstruction for a wound complication.
Measured: From surgery through postoperative day 90. 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Filler ComplicationStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edison Osorio, MD, plastic surgery, Principal investigator, Bioforma clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808957
- Sponsor's protocol ID
- 010
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not considered in the patient consent form
Publications
Patel NK, Henderson J, Uygur HS. Lateral Intercostal Artery Perforator Flap for Axillary Breast Reconstruction in a Previously Irradiated and Dissected Field. Indian J Plast Surg. 2026 Apr 15;59(3):232-236. doi: 10.1055/s-0046-1817012. eCollection 2026 Jun.
PubMed 42592441Aleman R, Carrasquilla A, Rodriguez-Zentner H, Lanzarini E, Sinagra D, Rancati A, Marinelli F, Ghiselli J, Gorreri MA, Aleman J, Dip F. Fluorescence-guided surgery in Latin America: A multinational survey of adoption, barriers, and collaboration. Surgery. 2026 Jul 21:110452. doi: 10.1016/j.surg.2026.110452. Online ahead of print.
PubMed 42608249Zhu Z, Hajek B, Jin Y, Stojanovski S, Jankulovska A, Angjushev D, Djikovski I, Jakupi N, Colanceski R, Ferati I, Antevski B, Vela I, Despotovski D, Tolevska Dimitrovska N, Bogdanovska Todorovska M, Kondov G, Kondov B, Nie S, Singhal S, Gruev V. A single-chip, dual-gain color-NIR camera for fluorescence-guided lung and breast cancer surgery. Light Sci Appl. 2026 Aug 21;15(1):359. doi: 10.1038/s41377-026-02437-9.
PubMed 42629355Moreno-Llorente P, Ruiz M, Garcia-Barrasa A, Recasens-Subias M, Larranaga I, Carnaval T, Videla S. Cost-effectiveness of angiography-guided thyroidectomy to prevent postoperative hypoparathyroidism: Spanish National Health System model-based analysis. BJS Open. 2026 Jul 3;10(4):zrag095. doi: 10.1093/bjsopen/zrag095.
PubMed 42485666Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.
PubMed 42495057
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal
- ClinicalTrials.gov ID
- NCT07808957
- Acronym / sponsor ID
- 010
- Keywords
- Indocyanine Green, Fluorescence Angiography, Perfusion Imaging, Gluteal Flap, Wound Dehiscence, Tissue Necrosis, Biopolymers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
This randomized clinical trial will compare indocyanine green fluorescence angiography-guided assessment with standard clinical assessment of gluteal flap perfusion during removal of permanent synthetic fillers. Participants will be assigned 1:1 to fluorescence-guided or standard management. The primary outcome is the occurrence of flap ischemia, ischemia-related wound dehiscence, or tissue necrosis through postoperative day 30. Dye-related adverse reactions, management changes, wound healing, infection, and reoperation will also be evaluated.
Detailed description
Adults undergoing gluteal filler-removal surgery with flap elevation will be randomized before definitive flap assessment. In both groups, the surgeon will record the planned closure after routine clinical evaluation. In the intervention group, intravenous indocyanine green and a standardized near-infrared imaging protocol will then be used to identify hypoperfused tissue. Management changes will follow a locked decision algorithm. The control group will proceed using clinical assessment alone. Postoperative wounds will be evaluated by assessors masked to allocation using standardized definitions and photographs through day 90. The trial will compare the 30-day composite ischemic complication rate and will evaluate necrosis, dehiscence, reoperation, time to healing, ICG-related reactions, and quantitative perfusion metrics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG-Guided Perfusion Assessment (Experimental) | Experimental | Drug: Indocyanine Green, Procedure: Standard Clinical Perfusion AssessmentStandard clinical assessment plus intraoperative indocyanine green fluorescence angiography. Hypoperfused regions may prompt additional excision, release of tension, or modification of closure according to the locked decision algorithm. |
| Standard Clinical Perfusion Assessment (Active Comparator) | Active comparator | Procedure: Standard Clinical Perfusion AssessmentFlap perfusion is assessed using routine clinical criteria without fluorescence imaging. All other perioperative care follows the same institutional protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years.
- Scheduled for elective gluteal permanent synthetic filler removal with flap elevation and primary closure.
- Expected availability of the study fluorescence imaging system.
- Ability to provide written informed consent and complete 90-day wound follow-up.
Key exclusion criteria (6 listed)
- Known hypersensitivity to indocyanine green.
- Pregnancy or breastfeeding.
- Emergency surgery, uncontrolled sepsis, or hemodynamic instability at the time of randomization.
- Severe hepatic dysfunction or another condition judged by anesthesia to make indocyanine green inappropriate.
- Prior enrollment in this trial for a contralateral or repeat operation.
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 |
|---|---|---|
| Indocyanine GreenPROPOSED regimen: 0.05 mg/kg intravenously followed by a saline flush after flap preparation and before definitive closure; one repeat dose may be used if the image is technically inadequate, within the approved local labeling and maximum dose. Final product, concentration, and dose must be confirmed. Linked arm/group(s): ICG-Guided Perfusion Assessment. | Drug | ICG-Guided Perfusion Assessment (Experimental) |
| Standard Clinical Perfusion AssessmentSurgeon assessment based on tissue color, capillary refill, dermal bleeding, temperature, and clinical judgment. This procedure is used in both groups; the control group does not receive fluorescence imaging. Linked arm/group(s): ICG-Guided Perfusion Assessment, Standard Clinical Perfusion Assessment. | Procedure or surgery | ICG-Guided Perfusion Assessment (Experimental), Standard Clinical Perfusion Assessment (Active Comparator) |
Primary outcome
Incidence of Ischemic Gluteal Flap Complications
Time frame: From surgery through postoperative day 30. 30 days
Proportion of participants with at least one adjudicated event: clinically significant flap ischemia requiring treatment, ischemia-related wound dehiscence, partial-thickness necrosis, or full-thickness necrosis. A masked committee will apply prespecified definitions using clinical records and standardized photographs.
5 secondary outcomes
Incidence of Partial- or Full-Thickness Flap Necrosis
Time frame: From surgery through postoperative day 30. 30 days
Intraoperative Change in Surgical Management
Time frame: From surgery through postoperative day 30. 30days
Time to Complete Wound Healing
Time frame: From surgery through postoperative day 90. 90 days
Incidence of Indocyanine Green-Related Adverse Reactions
Time frame: From indocyanine green administration through 24 hours after surgery. 1 day
Incidence of Reoperation for Wound Complications
Time frame: From surgery through postoperative day 90. 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 42592441Patel NK, Henderson J, Uygur HS. Lateral Intercostal Artery Perforator Flap for Axillary Breast Reconstruction in a Previously Irradiated and Dissected Field. Indian J Plast Surg. 2026 Apr 15;59(3):232-236. doi: 10.1055/s-0046-1817012. eCollection 2026 Jun.
- Background: PubMed 42608249Aleman R, Carrasquilla A, Rodriguez-Zentner H, Lanzarini E, Sinagra D, Rancati A, Marinelli F, Ghiselli J, Gorreri MA, Aleman J, Dip F. Fluorescence-guided surgery in Latin America: A multinational survey of adoption, barriers, and collaboration. Surgery. 2026 Jul 21:110452. doi: 10.1016/j.surg.2026.110452. Online ahead of print.
- Background: PubMed 42629355Zhu Z, Hajek B, Jin Y, Stojanovski S, Jankulovska A, Angjushev D, Djikovski I, Jakupi N, Colanceski R, Ferati I, Antevski B, Vela I, Despotovski D, Tolevska Dimitrovska N, Bogdanovska Todorovska M, Kondov G, Kondov B, Nie S, Singhal S, Gruev V. A single-chip, dual-gain color-NIR camera for fluorescence-guided lung and breast cancer surgery. Light Sci Appl. 2026 Aug 21;15(1):359. doi: 10.1038/s41377-026-02437-9.
- Background: PubMed 42485666Moreno-Llorente P, Ruiz M, Garcia-Barrasa A, Recasens-Subias M, Larranaga I, Carnaval T, Videla S. Cost-effectiveness of angiography-guided thyroidectomy to prevent postoperative hypoparathyroidism: Spanish National Health System model-based analysis. BJS Open. 2026 Jul 3;10(4):zrag095. doi: 10.1093/bjsopen/zrag095.
- Background: PubMed 42495057Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.
- Individual participant dataSharing planned: No. not considered in the patient consent form
Related trials for Soft Tissue Filler Complication
Not yet recruitingObservational study
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Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
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Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease
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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.
Edison Osorio, MD, plastic surgery principal investigator
Bioforma clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green and Standard Clinical Perfusion Assessment in people with Soft Tissue Filler Complication and Surgical Flap Ischemia, run by Research Inc at 1 site in Colombia.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Sep 2026. 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 Colombia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edison Osorio, MD, Plastic surgeon (+573226140611, info@edisonosorio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ischemic Gluteal Flap Complications (time frame: From surgery through postoperative day 30. 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808957, which also lists 5 linked publications.
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 9 Sep 2026.