Postoperative Wound InfectionSHOWERNCT04725916
Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
A study testing Showering and Restriction of Showering in people with Postoperative Wound Infection and Postoperative Complications, run by Sean Devitt at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Wound Infection, Postoperative Complications, Surgical Site Infection
- What is being tested?
- Showering and Restriction of Showering
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 15 Jul 2027
- 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
- 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
Geisinger Health
Danville, Pennsylvania, 17822
Sean Devitt, MD, 570-271-6335, sdevitt@geisinger.edu
Samantha Crissinger, BS, 570-271-7499, srcrissinger@geisinger.edu
About this study
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.
Read the detailed description
This is a prospective randomized, controlled, unblinded interventional feasibility trial evaluating the post-operative outcomes of surgical patients undergoing breast reduction or panniculectomy procedures. Approximately 100 eligible subjects will undergo their surgical procedure according to standard clinical guidelines. Unless clinically contraindicated, study surgeons will maintain consistent use of 10 Flat drains for all study participants to prevent any sampling bias.
Immediately after surgery is completed, the study investigator will randomize the subject into one of the 2 study arms. The randomization scheme will control for procedure type.
The study will not be blinded. The randomization assignment will be communicated to the care team and documented in the subject's electronic medical record to ensure that appropriate post-operative instruction is provided to the subject. Subjects will be notified of their study arm assignment at the time they receive their post-operative discharge instruction.
Subjects in both arms will complete a questionnaire related to quality of life post-operatively, as well as daily bathing specifics.
The following statistical methods will be used for the aims:
Aim 1: Collect and describe information related to outcome measures in addition to study data including number eligible, response rates, adherence/compliance rates.
Descriptive statistics will be provided for all study enrollment data, compliance information as well as data collected throughout the study including outcome measures and responses from the satisfaction survey.
Aim 2: To compare the surgical site complication rate of post-operative patients with drains who shower versus those who do not shower.
Complication rates between the two study arms will be compared using chi-squared tests, although these comparisons will not be conclusive since the study isn't powered to assess equivalence.
Aim 3: To compare patient post-operative satisfaction for those who shower versus those who do not shower.
Patient post-operative satisfaction between the two study arms will be compared using chi-squared tests, although these comparisons will not be conclusive since the study isn't powered to assess differences.
- Conditions
- Postoperative Wound Infection, Postoperative Complications, Surgical Site Infection, Drain Site Complication
- Being tested
- Showering, Restriction of Showering
- Keywords
- Panniculectomy, Breast reduction surgery, Postoperative showering, Surgical drain, Fleur-de-lis panniculectomy, Massive weight loss surgery
- Medical subject headings
- Surgical Wound Infection, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShoweringOther
Patients will be instructed to shower after surgery with drains in place
Restriction of ShoweringOther
Patients will be restricted from showering post operatively if they have drains in place
| Study group | Role | What they receive |
|---|---|---|
| Study Arm 1 | Active comparator | 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. Receives: Other: Showering |
| Study Arm 2 | Active comparator | 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. Receives: Other: Restriction of Showering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain site cellulitis
At each post operative appointment, the patient's drain sites will be examined for signs of cellulitis including tenderness to palpation and blanching erythema. The decision will be based on clinical exam by the physicians assistant, confirmed with the attending physician, and photos will be taken for documentation.
Measured: 12 weeks
Incisional cellulitis
At each post operative appointment, the patient's incision will be examined for signs of cellulitis including tenderness to palpation and blanching erythema. The decision will be based on clinical exam by the physicians assistant, confirmed with the attending physician, and photos will be taken for documentation.
Measured: 12 weeks
Seroma formation
At each post operative visit, the patient will be examined to rule out the presence of wound seroma. Any seroma requiring needle aspiration with removal of fluid will be documented as a positive seroma.
Measured: 12 weeks
Abscess formation
The patient will be examined at each post operative visit. Any collection of bacteria (abscess) that requires bedside drainage will be recorded as an abscess.
Measured: 12 weeks
Wound dehiscence
Development of wound dehiscence during follow-up period
Measured: 12 weeks
Patient Satisfaction
Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start23 Feb 2022
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Wound InfectionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sean Devitt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sean Devitt, Geisinger Clinic
- Investigators
- Sean Devitt, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725916
- Sponsor's protocol ID
- 2020-0970
- Acronym
- SHOWER
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2021
- Last updated
- 20 Feb 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)
- ClinicalTrials.gov ID
- NCT04725916
- Acronym / sponsor ID
- SHOWER / 2020-0970
- Conditions
- Postoperative Wound Infection, Postoperative Complications, Surgical Site Infection, Drain Site Complication
- Keywords
- Panniculectomy, Breast reduction surgery, Postoperative showering, Surgical drain, Fleur-de-lis panniculectomy, Massive weight loss surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sean DevittUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 27 Jan 2021 (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.
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.
Detailed description
This is a prospective randomized, controlled, unblinded interventional feasibility trial evaluating the post-operative outcomes of surgical patients undergoing breast reduction or panniculectomy procedures. Approximately 100 eligible subjects will undergo their surgical procedure according to standard clinical guidelines. Unless clinically contraindicated, study surgeons will maintain consistent use of 10 Flat drains for all study participants to prevent any sampling bias.
Immediately after surgery is completed, the study investigator will randomize the subject into one of the 2 study arms. The randomization scheme will control for procedure type.
The study will not be blinded. The randomization assignment will be communicated to the care team and documented in the subject's electronic medical record to ensure that appropriate post-operative instruction is provided to the subject. Subjects will be notified of their study arm assignment at the time they receive their post-operative discharge instruction.
Subjects in both arms will complete a questionnaire related to quality of life post-operatively, as well as daily bathing specifics.
The following statistical methods will be used for the aims:
Aim 1: Collect and describe information related to outcome measures in addition to study data including number eligible, response rates, adherence/compliance rates.
Descriptive statistics will be provided for all study enrollment data, compliance information as well as data collected throughout the study including outcome measures and responses from the satisfaction survey.
Aim 2: To compare the surgical site complication rate of post-operative patients with drains who shower versus those who do not shower.
Complication rates between the two study arms will be compared using chi-squared tests, although these comparisons will not be conclusive since the study isn't powered to assess equivalence.
Aim 3: To compare patient post-operative satisfaction for those who shower versus those who do not shower.
Patient post-operative satisfaction between the two study arms will be compared using chi-squared tests, although these comparisons will not be conclusive since the study isn't powered to assess differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1 | Active comparator | Other: ShoweringSubjects 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. |
| Study Arm 2 | Active comparator | Other: Restriction of ShoweringSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients having one of the following procedures at Geisinger Medical Center in which drains are placed
- ≥18 years of age
- Able and willing to provide consent
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| ShoweringPatients will be instructed to shower after surgery with drains in place | Other | Study Arm 1 |
| Restriction of ShoweringPatients will be restricted from showering post operatively if they have drains in place | Other | Study Arm 2 |
Primary outcome
Drain site cellulitis
Time frame: 12 weeks
At each post operative appointment, the patient's drain sites will be examined for signs of cellulitis including tenderness to palpation and blanching erythema. The decision will be based on clinical exam by the physicians assistant, confirmed with the attending physician, and photos will be taken for documentation.
Incisional cellulitis
Time frame: 12 weeks
At each post operative appointment, the patient's incision will be examined for signs of cellulitis including tenderness to palpation and blanching erythema. The decision will be based on clinical exam by the physicians assistant, confirmed with the attending physician, and photos will be taken for documentation.
Seroma formation
Time frame: 12 weeks
At each post operative visit, the patient will be examined to rule out the presence of wound seroma. Any seroma requiring needle aspiration with removal of fluid will be documented as a positive seroma.
Abscess formation
Time frame: 12 weeks
The patient will be examined at each post operative visit. Any collection of bacteria (abscess) that requires bedside drainage will be recorded as an abscess.
Wound dehiscence
Time frame: 12 weeks
Development of wound dehiscence during follow-up period
Patient Satisfaction
Time frame: 12 weeks
Measurement of patient satisfaction of post-operative ability to shower based on administration of a satisfaction survey
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 20 Feb 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.
Sean Devitt, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Showering and Restriction of Showering in people with Postoperative Wound Infection and Postoperative Complications, run by Sean Devitt 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Feb 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?
Contact Sean Devitt, MD (570-271-6335, sdevitt@geisinger.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drain site cellulitis (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 20 Feb 2026.