Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT06043557
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-24
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Reflection on Drain Placement
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: