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NCT Number: NCT07808996

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

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.

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Key information

About this study

Participants will receive standardized preoperative MRI morphometric mapping within 90 days before surgery. Two trained readers will measure the affected tissue block in three axes, estimate its volume, and record residual flap thickness at predefined surface landmarks. During the index filler-removal procedure, the landmarks will be reproduced and measured directly with a calibrated sterile device. The fresh specimen will be oriented, measured, and weighed before fixation. Agreement, bias, and prediction error will be quantified. Clinical follow-up through day 30 will determine whether thinner flaps or larger prediction errors are associated with ischemia-related wound complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Agreement Between MRI and Intraoperative Residual Flap Thickness

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

    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.

Secondary outcomes

  1. Agreement Between MRI and Fresh-Specimen Affected-Tissue Dimensions

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

    Maximum craniocaudal, mediolateral, and anteroposterior dimensions in centimeters will be compared between MRI and the oriented fresh specimen before fixation.

  2. Absolute Percentage Error in Predicted Affected-Tissue Volume

    Time frame: Preoperative MRI and the index surgical procedure. 1 day

    Absolute difference between MRI-predicted and specimen-derived volume divided by specimen-derived volume and multiplied by 100. Lower values indicate more accurate prediction.

  3. Incidence of Ischemic Wound Complications

    Time frame: From surgery through postoperative day 30. 30 days

    Proportion of participants with clinically documented flap ischemia, partial- or full-thickness tissue necrosis, or wound dehiscence judged to be related to tissue perfusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Edison Osorio, MD, Plastic surgeon

CONTACT

[email protected]

+573226140611

Sponsors and collaborators

Lead sponsor

Research Inc

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

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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