Recruiting

Observational Study

Sponsor:

Sean Devitt

Code:

NCT04725916

Conditions

Postoperative Wound Infection

Postoperative Complications

Surgical Site Infection

Drain Site Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Showering

Restriction of Showering

Study Details

Brief summary:

This is a prospective randomized, controlled, unblinded, interventional feasibility study to evaluate if showering with post operative drains in place leads to an increase in complications. The patients included in the study will be those undergoing breast reductions and panniculectomies at Geisinger Medical Center. The patients will be randomized post operatively into one of two groups: 1) patients instructed to shower with drains in place, and 2) patients instructed not to shower while they have drains in place.

Conditions

Postoperative Wound Infection

Postoperative Complications

Surgical Site Infection

Drain Site Complication

Study ID

NCT04725916

Start date

Feb 23, 2022

Status verified date

Feb, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients having one of the following procedures at Geisinger Medical Center in which drains are placed

  • Breast reduction
  • Lower panniculectomy
  • Fleur-de-lis panniculectomy
  • ≥18 years of age
  • Able and willing to provide consent

Exclusion Criteria:

  • Patients on antibiotics at the time of surgery
  • Patients sent home on antibiotics after surgery
  • Patients who work in healthcare with direct patient contact
  • Patients having a panniculectomy to be eligible for a kidney transplant
  • Patients having a ventral hernia repair at the time of the panniculectomy
  • Patients admitted to the hospital for >1 night

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Study Arm 1

Subjects assigned to Arm 1 will be instructed to shower daily beginning on post-operative Day 2 and maintain this daily schedule until the subject's 3-month standard of care clinic follow-up visit. They will receive specific instructions on caring for the incision site and drains until they are removed.

active comparator: Study Arm 2

Subjects assigned to Arm 2 will be instructed not to shower post-operatively until their surgical drains are removed. They will receive specific instructions on bathing and caring for the incision sites and drains.

Interventions

Showering

Patients will be instructed to shower after surgery with drains in place

Restriction of Showering

Patients will be restricted from showering post operatively if they have drains in place

Primary outcome measure

  • Drain site cellulitis [ Time Frame: 12 weeks ]
  • Incisional cellulitis [ Time Frame: 12 weeks ]
  • Seroma formation [ Time Frame: 12 weeks ]
  • Abscess formation [ Time Frame: 12 weeks ]
  • Wound dehiscence [ Time Frame: 12 weeks ]
  • Patient Satisfaction [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Sean Devitt, MD

570-271-6335sdevitt@geisinger.edu

Samantha Crissinger, BS

570-271-7499srcrissinger@geisinger.edu

Locations

Geisinger Health

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Sean Devitt, MD

570-271-6335sdevitt@geisinger.edu

Samantha Crissinger, BS

570-271-7499srcrissinger@geisinger.edu

More Information

Sponsor

Sean Devitt

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • Panniculectomy
  • Breast reduction surgery
  • Postoperative showering
  • Surgical drain
  • Fleur-de-lis panniculectomy
  • Massive weight loss surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sean Devitt on 2026-02-20.