Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty

June 26, 2024 updated by: Pola Fayez Fanos, Sohag University

Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty : Randomized Clinical Study

The aim of the present study is to:

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vacuum Drain insertion at abdominoplasty surgery
insert the active drain after adominoplasty with radivac container
Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
Experimental: Passive Drain insertion at abdominoplasty surgery
insert the passive drain after adominoplasty with collecting bag
Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the subcutaneous collection with vaccum drain
Time Frame: 10 days
the subcutaneous collection with Vacuum Drain at abdominoplasty surgery regarding : Incidence of postoperative complications
10 days
the subcutaneous collection with passive drain
Time Frame: 10 days
the subcutaneous collection with passive Drain at abdominoplasty surgery regarding : Incidence of postoperative complications
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med-23-12-10MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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