AbdominoplastyNCT06043557
Patient Satisfaction and Reflection on Drain Placement
A study testing Drain Placement in people with Abdominoplasty and Panniculectomy, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominoplasty, Panniculectomy
- What is being tested?
- Drain Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with unilateral drain placement, unable to sign English language consent form
- Patient under the age of 18.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy
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.
Read the 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.
- Conditions
- Abdominoplasty, Panniculectomy
- Being tested
- Drain Placement
- Keywords
- Abdominoplasty, plastic surgery, panniculectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drain PlacementProcedure or surgery
Surgical placement of drain based on subject randomization.
| Study group | Role | What they receive |
|---|---|---|
| left side lateral and right side medial | Active comparator | left side lateral and right side medial Receives: Procedure: Drain Placement |
| right side lateral with left side medial | Active comparator | right side lateral with left side medial Receives: Procedure: Drain Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 1 week post surgery
Secondary outcomes (1)
Number of days until drain removed
tracking number of days
Measured: day of surgery up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Katz, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043557
- Sponsor's protocol ID
- IRB00100958
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Reflection on Drain Placement in Abdominoplasty and Panniculectomy
- ClinicalTrials.gov ID
- NCT06043557
- Acronym / sponsor ID
- IRB00100958
- Conditions
- Abdominoplasty, Panniculectomy
- Keywords
- Abdominoplasty, plastic surgery, panniculectomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| left side lateral and right side medial | Active comparator | Procedure: Drain Placementleft side lateral and right side medial |
| right side lateral with left side medial | Active comparator | Procedure: Drain Placementright side lateral with left side medial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with unilateral drain placement, unable to sign English language consent form
- Patient under the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drain PlacementSurgical placement of drain based on subject randomization. | Procedure or surgery | left side lateral and right side medial, right side lateral with left side medial |
Primary outcome
Patient preference of surgical drain placement
Time frame: 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 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 secondary outcome
Number of days until drain removed
Time frame: day of surgery up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Katz, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain Placement in people with Abdominoplasty and Panniculectomy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preference of surgical drain placement (time frame: 1 week post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.