Role of Preservation of Scarpa's Fascia in Abdominoplasty

Summary

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.

Conditions

• Abdominoplasty

Interventions

PROCEDURE

Abdominoplasty-Scarpa's fascia preservation

Thicker abdominal flaps will be preserved during the surgery.

PROCEDURE

Abdominoplasty-Scarpa's fascia ablation

Thinner abdominal flaps will be preserved during 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).

Sponsors & Collaborators

• Loma Linda University

  lead OTHER

Principal Investigators

• Michael E Hill, MD, PhD · Loma Linda University Department of Plastic Surgery

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2015-08-31

Countries

• United States

Study Locations