Patient Satisfaction and Reflection on Drain Placement

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06043557
Collaborator
(none)
50
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Drain Placement
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: left side lateral and right side medial

left side lateral and right side medial

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

Active Comparator: right side lateral with left side medial

right side lateral with left side medial

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

Outcome Measures

Primary Outcome Measures

  1. 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 hygeine) 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

  1. Number of days until drain removed [day of surgery up to 10 days]

    tracking number of days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Adam Katz, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT06043557
Other Study ID Numbers:
  • IRB00100958
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences

Study Results

No Results Posted as of Sep 21, 2023