Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal

NCT07808996 | Not Yet Recruiting

• 1 other identifier: 008
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective agreement study will compare preoperative MRI measurements with direct surgical measurements in adults undergoing removal of gluteal tissue affected by permanent synthetic fillers. MRI will estimate affected-tissue dimensions and residual skin-flap thickness at predefined landmarks. During surgery, the same flap landmarks and the fresh excised specimen will be measured. The primary outcome is agreement between MRI and intraoperative flap thickness; postoperative ischemia, wound dehiscence, and necrosis will be followed through 30 days.

Conditions

Gluteal Tissue Ischemia Risk; Foreign-Body Reaction; Soft Tissue Filler Complication

Keywords

Gluteal Reconstruction; Specimen Measurement; Flap Thickness; Surgical Planning; Magnetic Resonance Imaging; Biopolymers

Outcome Measures

Primary Outcomes (1)

• Agreement Between MRI and Intraoperative Residual Flap Thickness

  Residual skin-subcutaneous flap thickness in millimeters will be measured at predefined mapped landmarks on MRI and directly during surgery. Agreement will be summarized using intraclass correlation, mean bias, 95% limits of agreement, and absolute error.

  Preoperative MRI within 90 days before surgery and the index surgical procedure. 90 days

Secondary Outcomes (3)

• Agreement Between MRI and Fresh-Specimen Affected-Tissue Dimensions

  Preoperative MRI within 90 days before surgery and immediately after specimen removal during the index operation. 90 days

• Absolute Percentage Error in Predicted Affected-Tissue Volume

  Preoperative MRI and the index surgical procedure. 1 day

• Incidence of Ischemic Wound Complications

  From surgery through postoperative day 30. 30 days

Study Arms (1)

MRI-to-Surgery Agreement Cohort (Cohort)

Participants undergo preoperative MRI morphometry followed by standardized intraoperative flap and specimen measurements during clinically indicated filler removal.

Diagnostic Test: Preoperative MRI Morphometric Mapping; Procedure: Standardized Intraoperative and Fresh-Specimen Measurement

Interventions

Standardized Intraoperative and Fresh-Specimen Measurement PROCEDURE

Before closure, residual flap thickness will be measured with a calibrated sterile device at the same mapped landmarks without compressing the tissue. The fresh excised block will be oriented and measured in three axes before fixation. Specimen weight will also be recorded. Linked arm/group(s): MRI-to-Surgery Agreement Cohort.

MRI-to-Surgery Agreement Cohort (Cohort)

Preoperative MRI Morphometric Mapping DIAGNOSTIC_TEST

Three orthogonal dimensions of the affected block and residual flap thickness at fixed surface landmarks will be measured on MRI by two trained readers. Affected-tissue volume will be estimated using segmentation when available and a prespecified geometric approximation otherwise. Linked arm/group(s): MRI-to-Surgery Agreement Cohort.

MRI-to-Surgery Agreement Cohort (Cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults scheduled for surgical excision of gluteal tissue affected by permanent synthetic fillers after preoperative MRI.

You may qualify if:

• Age 18 years or older.
• Gluteal permanent synthetic filler disease scheduled for elective surgical excision.
• Preoperative MRI performed within 90 days before surgery using the study measurement protocol.
• Planned skin/subcutaneous flap elevation that permits direct thickness measurement at predefined landmarks.
• Written informed consent.

You may not qualify if:

• Emergency surgery or active uncontrolled infection that prevents standardized preoperative imaging or measurement.
• Prior surgery causing loss of the predefined landmarks or making paired measurement impossible.
• Nondiagnostic MRI or incomplete coverage of the planned operative field.
• Specimen fragmentation that prevents standardized fresh-specimen dimension measurement for the secondary endpoint.
• Inability to complete 30-day wound follow-up.

Sponsors & Collaborators

• Research Inc: lead

MeSH Terms

Conditions

Foreign-Body Reaction

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign Bodies; Wounds and Injuries

Study Officials

• Edison Osorio, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edison Osorio, MD, Plastic surgeon

CONTACT

+573226140611; info@edisonosorio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share