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Patient Satisfaction and Reflection on Drain Placement

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Invitation-only

Conditions

Panniculectomy
Abdominoplasty

Treatments

Procedure: Drain Placement

Study type

Interventional

Funder types

Other

Identifiers

NCT06043557
IRB00100958

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

left side lateral and right side medial
Active Comparator group
Description:
left side lateral and right side medial
Treatment:
Procedure: Drain Placement
right side lateral with left side medial
Active Comparator group
Description:
right side lateral with left side medial
Treatment:
Procedure: Drain Placement

Trial contacts and locations

1

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Central trial contact

Caleb suggs; Oddulia Santamaria

Data sourced from clinicaltrials.gov

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