Role of Preservation of Scarpa's Fascia in Abdominoplasty

Role of Preservation of Scarpa's Fascia in Abdominoplasty: a Prospective Trial

The purpose of this study is to determine whether leaving a thicker layer -which preserves the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases the damage to the lymphatic system.

In order to investigate the effect of leaving a thinner or slightly thicker layer intact during a tummy tuck, patients who are already planning to undergo the surgery, and who agree to participate, will be randomly assigned to two groups in a manner similar to flipping a coin. The first group will have their abdominoplasty performed with a thinner layer of abdominal wall left in place while the second group will have the surgery with a slightly thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of care, and the aesthetic outcomes will not be negatively impacted by either of the options.

Before and after the surgery, a procedure called lymphoscintigraphy will be performed. Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is injected and then detected by a special camera. The pictures provided by the lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will help investigators to know what method of performing the tummy tuck leaves the lymphatic system most intact.

In addition, photographs of each patient's abdomen will be taken using a special camera that allows investigators to put the photographs in the computer and compile a 3-dimensional image. Investigators will be able to look at the volume changes from swelling after the surgery using these pictures. Finally, an ultrasound will be used to help identify any seromas, or fluid collections, that may form after the surgery.

The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid draining lymphatic system and whether or not that effects recovery after the procedure.

Study Overview

• Status: Withdrawn
• Conditions: Abdominoplasty
• Intervention / Treatment: Procedure: Abdominoplasty-Scarpa's fascia preservation; Device: Lymphoscintigraphy; Device: 3D Imaging; Device: Abdominal ultrasound; Procedure: Abdominoplasty-Scarpa's fascia ablation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Department of Plastic and Reconstructive Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients ages 18-65 years who are planning to undergo elective abdominoplasty

Exclusion Criteria:

• patients with contraindications to lymphoscintigraphy
• patients with contraindications to abdominoplasty
• previous abdominal surgery or traumatic perforation

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Abdominoplasty-Scarpa's fascia preservation; Scarpa's fascia preservation Lymphoscintigraphy 3D imaging Abdominal ultrasound	Procedure: Abdominoplasty-Scarpa's fascia preservation; Thicker abdominal flaps will be preserved during the surgery.; Device: Lymphoscintigraphy; Post-operative lymphatic imaging will be conducted using a common radiographic medium; Device: 3D Imaging; Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.; Device: Abdominal ultrasound; Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).
ACTIVE_COMPARATOR: Abdominoplasty-Scarpa's fascia ablation; Scarpa's fascia ablation Lymphoscintigraphy 3D imaging Abdominal ultrasound	Device: Lymphoscintigraphy; Post-operative lymphatic imaging will be conducted using a common radiographic medium; Device: 3D Imaging; Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.; Device: Abdominal ultrasound; Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).; Procedure: Abdominoplasty-Scarpa's fascia ablation; Thinner abdominal flaps will be preserved during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphatic preservation	Lymphatic integrity will be measured pre-operatively and then again two weeks post-operatively in order to evaluate preservation of the lymphatic system.	Two weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edema	Edema will be measured by calculating volumetry using 3-dimensional photography	Up to six months post-operatively
Seroma formation	Seroma formation will be evaluated by ultrasound at routine post-operative clinic appointments	Up to six months post-operatively

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Michael E Hill, MD, PhD, Loma Linda University Department of Plastic Surgery

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (ESTIMATE): May 16, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 5120289