Patient Satisfaction and Reflection on Drain Placement

Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Abdominoplasty; Panniculectomy
• Intervention / Treatment: Procedure: Drain Placement

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Drain Placement; Surgical placement of drain based on subject randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preference of surgical drain placement	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.)	1 week post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days until drain removed	tracking number of days	day of surgery up to 10 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Adam Katz, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Abdominoplasty; plastic surgery; panniculectomy
• Other Study ID Numbers: IRB00100958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No