Role of Preservation of Scarpa's Fascia in Abdominoplasty

Abdominoplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02140385
• Other study ID #: 5120289
• Status: Withdrawn
• Phase: N/A
• First received: September 24, 2013
• Last updated: August 27, 2015
• Start date: July 2014

Study information

• Verified date: August 2015
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abdominoplasty

Intervention

Procedure:
• Abdominoplasty-Scarpa's fascia preservation
Thicker abdominal flaps will be preserved during the surgery.
• 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
• 3D Imaging
Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.
• Abdominal ultrasound
Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).

Locations

Country	Name	City	State
United States	Loma Linda University Department of Plastic and Reconstructive Surgery	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Edema	Edema will be measured by calculating volumetry using 3-dimensional photography	Up to six months post-operatively	No
Secondary	Seroma formation	Seroma formation will be evaluated by ultrasound at routine post-operative clinic appointments	Up to six months post-operatively	No