Patient Satisfaction and Reflection on Drain Placement

Not Applicable

• Conditions: Panniculectomy; Abdominoplasty
• Interventions: Procedure: Drain Placement

• Registration Number: NCT06043557
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-21
• Study Start: 2024-01-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
left side lateral and right side medial	Drain Placement	left side lateral and right side medial
right side lateral with left side medial	Drain Placement	right side lateral with left side medial

Primary Outcome Measures

Name	Time	Method
Patient preference of surgical drain placement	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

Name	Time	Method
Number of days until drain removed	day of surgery up to 10 days	tracking number of days

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States