Drain Placement for Tummy Tuck

Overseen By Caleb suggs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Unilateral drain placement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

50 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Drain Placement for tummy tuck?

The research suggests that placing drains during abdominal surgeries, like those for gastric cancer or gynecological procedures, does not provide additional benefits in terms of reducing complications or improving recovery times. This implies that using drains for a tummy tuck might not be necessary or particularly effective. ^{1 2 3 4 5}

Is drain placement safe for tummy tuck surgeries?

Some studies suggest that using drains in surgeries like tummy tucks can lead to complications such as infections, pain, and skin irritation. Other research shows that drainless techniques can be safe and may reduce risks like fluid buildup under the skin. ^{3 6 7 8 9}

How does drain placement for tummy tuck differ from other treatments?

Drain placement during a tummy tuck is a traditional method to prevent fluid buildup, but recent studies suggest that drainless techniques using advanced suturing methods can reduce the risk of fluid accumulation (seroma) more effectively. This makes the drainless approach potentially more comfortable and less complicated for patients compared to the traditional use of drains. ^{4 7 9 10 11}

What is the purpose of this trial?

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.

Research Team

Adam Katz, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults aged 18 or older who are having a tummy tuck or panniculectomy at the Department of Plastic and Reconstructive Surgery. Participants must be able to sign an English language consent form.

Inclusion Criteria

I am a patient of the Plastic and Reconstructive Surgery department.

I am having surgery to remove excess belly skin or fat.

You are capable of signing a consent form in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo abdominoplasty and/or panniculectomy with randomized drain placement

1 day

Surgery day

Post-operative Evaluation

Participants complete surveys to evaluate their experience with the drains

1 week

Planned post-operative visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 days

Treatment Details

Interventions

• Drain Placement

Trial Overview The study is testing two different drain placements in patients after abdominoplasty or panniculectomy surgery. Each participant will have one drain placed medially and another laterally, with their experiences compared through surveys during post-op visits.

Participant Groups

Group I: right side lateral with left side medial Active Control 1 Intervention

right side lateral with left side medial

Group II: left side lateral and right side medial Active Control 1 Intervention

left side lateral and right side medial

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Gastric cancer surgery without drains: a prospective randomized trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

The effect of abdominal drainage on post-operative morbidity; a prospective cohort study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Is It Necessary To Place Prophylactically an Abdominal Drain To Prevent Surgical Site Infection in Abdominal Operations? A Systematic Meta-Review. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Large ventral hernias: to drain… And what to drain… That is the question! [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Prophylactic Drain Versus No Drain in Curative Gastric Cancer Surgery-A Randomized Controlled Trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Still no evidence for drains in bariatric surgery]. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Utility of the Drainless Abdominoplasty in the Post-Bariatric Surgery Patient. [2018]

8. France pubmed.ncbi.nlm.nih.gov

Early drain removal does not increase the rate of surgical site infections following an open transversus abdominis release. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Reduced Seroma Risk in Drainless Abdominoplasty Using Running Barbed Sutures: A 10-Year, Multicenter Retrospective Analysis. [2021]

10. France pubmed.ncbi.nlm.nih.gov

[Abdominoplasties: Do we still need to drain in 2021?] [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Abdominoplasty flap elevation in a more superficial plane: decreasing the need for drains. [2022]