Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty

NCT ID: NCT06486298

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-11-01

Brief Summary

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The aim of the present study is to:

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

Detailed Description

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Conditions

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Abdominoplasty Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Vacuum Drain insertion at abdominoplasty surgery

insert the active drain after adominoplasty with radivac container

Group Type ACTIVE_COMPARATOR

Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

Intervention Type DEVICE

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

Passive Drain insertion at abdominoplasty surgery

insert the passive drain after adominoplasty with collecting bag

Group Type EXPERIMENTAL

Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

Intervention Type DEVICE

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

Interventions

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Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Pola Fayez Fanos

plastic surgery departement

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag Hospital University

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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pola fayez fanos

Role: primary

01228191595

Role: backup

01228191595

Other Identifiers

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Soh-Med-23-12-10MS

Identifier Type: -

Identifier Source: org_study_id

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