Patient Satisfaction and Reflection on Drain Placement

Abdominoplasty Clinical Trial

Official title:

Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06043557
• Other study ID #: IRB00100958
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominoplasty
• Panniculectomy

Intervention

Procedure:
• Drain Placement
Surgical placement of drain based on subject randomization.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days until drain removed	tracking number of days	day of surgery up to 10 days