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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

220 Participants
are divided into 1 treatment group
Group A: MRI-to-Surgery Agreement Cohort (Cohort)2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Agreement Between MRI and Fresh-Specimen Affected-Tissue Dimensions

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

Time frame
Preoperative MRI within 90 days before surgery and immediately after specimen removal during the index operation. 90 days
2

Absolute Percentage Error in Predicted Affected-Tissue Volume

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

Time frame
Preoperative MRI and the index surgical procedure. 1 day
3

Incidence of Ischemic Wound Complications

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

Time frame
From surgery through postoperative day 30. 30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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