Role of Preservation of Scarpa's Fascia in Abdominoplasty

NCT02140385 | Withdrawn DMC

• 1 other identifier: 5120289
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Edema

  Up to six months post-operatively

• Seroma formation

  Up to six months post-operatively

Study Arms (2)

Abdominoplasty-Scarpa's fascia preservation

ACTIVE COMPARATOR

Scarpa's fascia preservation Lymphoscintigraphy 3D imaging Abdominal ultrasound

Procedure: Abdominoplasty-Scarpa's fascia preservation; Device: Lymphoscintigraphy; Device: 3D Imaging; Device: Abdominal ultrasound

Abdominoplasty-Scarpa's fascia ablation

ACTIVE COMPARATOR

Scarpa's fascia ablation Lymphoscintigraphy 3D imaging Abdominal ultrasound

Procedure: Abdominoplasty-Scarpa's fascia ablation; Device: Lymphoscintigraphy; Device: 3D Imaging; Device: Abdominal ultrasound

Interventions

Abdominoplasty-Scarpa's fascia preservation PROCEDURE

Thicker abdominal flaps will be preserved during the surgery.

Abdominoplasty-Scarpa's fascia preservation

Abdominoplasty-Scarpa's fascia ablation PROCEDURE

Thinner abdominal flaps will be preserved during surgery.

Abdominoplasty-Scarpa's fascia ablation

Lymphoscintigraphy DEVICE

Post-operative lymphatic imaging will be conducted using a common radiographic medium

Abdominoplasty-Scarpa's fascia ablation; Abdominoplasty-Scarpa's fascia preservation

3D Imaging DEVICE

Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.

Abdominoplasty-Scarpa's fascia ablation; Abdominoplasty-Scarpa's fascia preservation

Abdominal ultrasound DEVICE

Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).

Abdominoplasty-Scarpa's fascia ablation; Abdominoplasty-Scarpa's fascia preservation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Department of Plastic and Reconstructive Surgery

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Lymphoscintigraphy; Imaging, Three-Dimensional

Intervention Hierarchy (Ancestors)

Radionuclide Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Michael E Hill, MD, PhD

  Loma Linda University Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: May 16, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

US (1)