Patient Satisfaction and Reflection on Drain Placement

NCT06043557 | Enrolling By Invitation

• 1 other identifier: IRB00100958
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominoplasty; Panniculectomy

Keywords

Abdominoplasty; plastic surgery; panniculectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of days until drain removed

  day of surgery up to 10 days

Study Arms (2)

left side lateral and right side medial

ACTIVE COMPARATOR

left side lateral and right side medial

Procedure: Drain Placement

right side lateral with left side medial

ACTIVE COMPARATOR

right side lateral with left side medial

Procedure: Drain Placement

Interventions

Drain Placement PROCEDURE

Surgical placement of drain based on subject randomization.

left side lateral and right side medial; right side lateral with left side medial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Adam Katz, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)