Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty

NCT06486298 | Recruiting

• 1 other identifier: Soh-Med-23-12-10MS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to: Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

Conditions

Abdominoplasty Surgery

Keywords

abdominoplasty surgery

Outcome Measures

Primary Outcomes (2)

• the subcutaneous collection with vaccum drain

  the subcutaneous collection with Vacuum Drain at abdominoplasty surgery regarding : Incidence of postoperative complications

  10 days

• the subcutaneous collection with passive drain

  the subcutaneous collection with passive Drain at abdominoplasty surgery regarding : Incidence of postoperative complications

  10 days

Study Arms (2)

Vacuum Drain insertion at abdominoplasty surgery

ACTIVE COMPARATOR

insert the active drain after adominoplasty with radivac container

Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

Passive Drain insertion at abdominoplasty surgery

EXPERIMENTAL

insert the passive drain after adominoplasty with collecting bag

Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

Interventions

Vacuum Drain and Passive Drain insertion at abdominoplasty surgery DEVICE

Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

Passive Drain insertion at abdominoplasty surgery; Vacuum Drain insertion at abdominoplasty surgery

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cooperative male and female patients aged between 20-60 years old.
• All patients in the study presented with varying degrees of excess abdominal skin and adipose tissue, along with a range of underlying abdominal muscle laxity, following volumetric changes of the abdominal cavity.
• These patients may undergo after bariatric surgery, dietry weight loss or after multiple pregnancies.

You may not qualify if:

• Uncooperative patients unwilling to give consent.
• Those unsuitable for abdominoplasty surgery, BMI \>30 and those on antiplatelet medication.
• Unfit for surgery and patients with allergies to any of the anesthesia components.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Hospital University

Sohag, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: plastic surgery departement

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: July 3, 2024
• Study Start: December 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

EG (1)