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Enrolling by invitation NCT06043557

Patient Satisfaction and Reflection on Drain Placement

No phase Interventional Abdominoplasty Panniculectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drain Placement.
Who it may be relevant to
Registry conditions: Abdominoplasty, Panniculectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy

Overview

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.

Interventions

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

Primary outcome measures

  • Patient preference of surgical drain placement [Time frame: 1 week post surgery]
Secondary outcome measures (1)
  • Number of days until drain removed [Time frame: day of surgery up to 10 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT06043557 · IRB00100958

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗