Patient Satisfaction and Reflection on Drain Placement

NCT ID: NCT06043557

Last Updated: 2025-08-24

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this research study is to evaluate the ideal drain placement in patients undergoing abdominoplasty or panniculectomy. There are currently no patient reported outcome measurements on ideal drain placement and this study aims to collect objective and patient reported measures to standardize ideal drain placement.

In this study a medially and laterally placed drain will be compared to each other in each study participant. In this study subject will have two drains. One will be lateral and one medial. The drains will be secured and dressed in the same manner. At subjects planned post-operative visits, subjects will be asked to complete surveys to evaluate their experience with the drains. This study will not require additional clinic visits for study purposes.

Detailed Description

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The primary goal of this proposal is to assess patient perspectives and satisfaction with the location of their drains after abdominoplasty and/or panniculectomy. This will be conducted as a prospective observational trial, where patients with scheduled abdominoplasty and/or panniculectomy will be invited to participate. Patients will be randomized to either A) left side lateral and right side medial or B) right side lateral with left side medial. Randomization will occur before study initiation with group A or group B being assigned to a study enrollment number.

Conditions

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Abdominoplasty Panniculectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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left side lateral and right side medial

left side lateral and right side medial

Group Type ACTIVE_COMPARATOR

Drain Placement

Intervention Type PROCEDURE

Surgical placement of drain based on subject randomization.

right side lateral with left side medial

right side lateral with left side medial

Group Type ACTIVE_COMPARATOR

Drain Placement

Intervention Type PROCEDURE

Surgical placement of drain based on subject randomization.

Interventions

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Drain Placement

Surgical placement of drain based on subject randomization.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 18 or older
* patient of Department of Plastic and Reconstructive Surgery
* able to sign English language Consent form
* undergoing either abdominoplasty and/or panniculectomy.

Exclusion Criteria

* Patients with unilateral drain placement, unable to sign English language consent form
* Patient under the age of 18.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00100958

Identifier Type: -

Identifier Source: org_study_id

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