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Patient Satisfaction and Reflection on Drain Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06043557
Recruitment Status : Enrolling by invitation
First Posted : September 21, 2023
Last Update Posted : January 29, 2024
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abdominoplasty Panniculectomy Procedure: Drain Placement Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy
Actual Study Start Date : January 1, 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Active Comparator: left side lateral and right side medial
left side lateral and right side medial
Procedure: Drain Placement
Surgical placement of drain based on subject randomization.

Active Comparator: right side lateral with left side medial
right side lateral with left side medial
Procedure: Drain Placement
Surgical placement of drain based on subject randomization.




Primary Outcome Measures :
  1. Patient preference of surgical drain placement [ Time Frame: 1 week post surgery ]

    Patients will complete a survey about their experience with the pertinent securement method/drain site - questions are essay style without a score or range

    In the survey we created the level of negative factors (pulling, tugging, pain) as well as positive (ease of drain care, ease of personal hygiene) will be on a 1-100 scale. Therefore each side will get a conglomerate score of the following:

    Total score = positive scores (average) - negative scores (average)

    This result will be tabulated for each patient and used as a group analysis for preference. (Average scores for each side from all patients compared to one another.)



Secondary Outcome Measures :
  1. Number of days until drain removed [ Time Frame: day of surgery up to 10 days ]
    tracking number of days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043557


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Adam Katz, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT06043557    
Other Study ID Numbers: IRB00100958
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: January 29, 2024
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Abdominoplasty
plastic surgery
panniculectomy