Showering With Drains for Surgical Site Infection Risk

(SHOWER Trial)

Overseen By Samantha Crissinger, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sean Devitt

Must not be taking: Antibiotics

Disqualifiers: Healthcare workers, Kidney transplant, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether showering with surgical drains in place increases the risk of complications for patients who have undergone breast reductions or panniculectomies (removal of excess skin and fat from the lower abdomen). Participants will be randomly assigned to one of two groups: one group can shower starting two days after surgery, while the other must wait until their drains are removed. The goal is to determine if recovery differs between these approaches. Individuals who have had breast reductions or certain types of tummy tucks at Geisinger Medical Center and are not on antibiotics might be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to valuable research that could enhance post-surgical care practices.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on antibiotics, you would not be eligible to participate.

What prior data suggests that showering with drains is safe for surgical patients?

In a previous study, people who showered soon after surgery had an infection rate of only 0.9% within 30 days. This suggests that showering is safe and does not increase the risk of infections. Another study found that showering shortly after surgery does not lead to more wound infections compared to simply covering the wound without bathing. These findings indicate that showering after surgery might be safe and well-tolerated for patients. While not showering is generally considered a safe standard practice, the study aims to determine if showering could be just as safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it investigates how showering habits might impact the risk of surgical site infections for patients with drains. Currently, patients are typically advised to avoid showering until drains are removed to minimize infection risk. However, this trial explores whether allowing patients to shower earlier, beginning on post-operative Day 2, could be safe and possibly beneficial. By comparing these two approaches, researchers hope to find out if early showering could enhance patient comfort and recovery without increasing infection risk.

What evidence suggests that showering with drains is effective for reducing surgical site infection risk?

Research has shown that showering soon after surgery does not increase the risk of infections at the surgical site. Studies have found that patients who shower shortly after their operation experience similar rates of wound infections as those who do not shower. One study reported an infection rate of just 0.9% within 30 days, supporting the safety of early showering. In this trial, participants in one arm will be instructed to shower daily beginning on post-operative Day 2, while those in the other arm will wait until their surgical drains are removed. Showering with drains in place has been found to be safe and does not lead to more complications. These findings suggest that patients can safely shower soon after surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Sean Devitt, MD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having breast reductions or panniculectomies at Geisinger Medical Center and will have drains placed post-surgery. They must be able to consent. It's not for those on antibiotics, healthcare workers with patient contact, patients staying in the hospital >1 night, or needing a panniculectomy before kidney transplant.

Inclusion Criteria

Able and willing to provide consent

I am having a procedure at Geisinger Medical Center that requires drains.

I have had a breast reduction.

Exclusion Criteria

I have been hospitalized for more than one night.

Patients who work in healthcare with direct patient contact

I was prescribed antibiotics after my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Randomization

Participants undergo breast reduction or panniculectomy procedures and are randomized into one of two study arms post-operatively

Immediate post-operative period

1 visit (in-person)

Post-operative Care

Participants follow specific post-operative instructions based on their assigned study arm, including showering or not showering with drains in place

12 weeks

Regular post-operative visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of wound dehiscence, patient satisfaction, and other complications

12 weeks

Regular post-operative visits

What Are the Treatments Tested in This Trial?

Interventions

• Restriction of Showering
• Showering

Trial Overview

The SHOWER Study is testing whether showering with surgical drains after breast reductions or panniculectomies affects infection rates. Participants are randomly assigned to either shower with the drains in place or avoid showering until the drains are removed.

How Is the Trial Designed?

Group I: Study Arm 1 Active Control 1 Intervention

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.

Group II: Study Arm 2 Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Sean Devitt

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

In a study of 110 elective foot and ankle surgery patients, allowing early daily showering did not significantly increase the risk of postoperative surgical site infections (SSI), which had an overall rate of 4.5%, all classified as mild.

The study found that common risk factors for infection did not significantly predict the occurrence of infections, suggesting that early exposure of the surgical site may be safe without increasing infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of surgical site infection in the foot and ankle with early exposure and showering of surgical sites: a prospective observation. Feilmeier, M., Dayton, P., Sedberry, S., et al.[2014]

In a study with 10 healthy volunteers, three preoperative showers using 4% chlorhexidine detergent significantly reduced skin flora, achieving optimal disinfection before surgery.

The first two showers were most effective, with a 93.55% and 77.49% reduction in skin flora, while additional showers or baths did not provide further significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationalizing whole body disinfection. Byrne, DJ., Napier, A., Cuschieri, A.[2019]

A study involving 114 patients undergoing elective plastic surgery found that preoperative showers with povidone-iodine significantly reduced staphylococcal skin colonization, with 33% of patients showing no microorganism growth after showering compared to 0% in the control group.

The use of povidone-iodine did not significantly affect the colonization of other microorganisms like fungi and enterobacteria, indicating its specific efficacy against staphylococci in the context of surgical preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of povidone-iodine preoperative showers on skin colonization in elective plastic surgery procedures. Veiga, DF., Damasceno, CAV., Filho, JV., et al.[2022]

Surgical drains can increase the risk of postoperative complications in clean wounds, so they should only be used when absolutely necessary.

Drains should be carefully managed, including proper aseptic preparation and timely removal, to minimize risks and complications, especially avoiding placement near critical areas like anastomotic sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and misuse of drains in surgical practice. Roush, JK.[2005]

A study involving 30 patients who underwent breast reconstruction with DIEP flaps found that postoperative showering is safe for patients with closed suction drainage, as it did not increase complications such as infections.

Patients were allowed to shower when they had two or fewer drainage tubes, and no significant differences in complications were observed among those with different numbers of drains, indicating that early showering can be safely incorporated into postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Showering for Patients With Closed Suction Drainage: A Retrospective Cohort Study of Deep Inferior Epigastric Perforator Flap Breast Reconstructions. Ogawa, H., Tahara, S.[2022]

A systematic review of nine studies involving 2150 patients found no increased risk of infection for those allowed to shower or bathe before suture removal compared to those who kept their surgical site dry.

This challenges the common practice among foot and ankle surgeons of keeping surgical incisions covered and dry, suggesting that allowing normal hygiene may not compromise infection control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does postoperative showering or bathing of a surgical site increase the incidence of infection? A systematic review of the literature. Dayton, P., Feilmeier, M., Sedberry, S.[2018]

In a study involving 170 patients, allowing water contact with freshly closed surgical wounds 24 hours after surgery resulted in no observed cases of wound infection.

This finding suggests that the traditional guideline against water contact may not be necessary, as the infection rate in the water-contact group was comparable to a historical control group with a 0.6% infection rate, although the difference was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative wound healing in wound-water contact]. Köninger, J., Russ, M., Schmidt, R., et al.[2013]

Preoperative chlorhexidine showers significantly reduced skin colonization by coagulase-negative staphylococci and yeasts in patients undergoing plastic surgery on the trunk.

Despite the reduction in skin colonization, there was no observed difference in postoperative infection rates, suggesting that while chlorhexidine is effective for skin preparation, it may not impact overall infection outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the effectiveness of chlorhexidine showers before elective plastic surgical procedures. Veiga, DF., Damasceno, CA., Veiga-Filho, J., et al.[2015]

In a study of 5,571 surgical patients, 4.6% developed post-surgical wound infections, with the presence of drains significantly increasing the risk of infection by 4.1 times (p < 0.001).

The use of drains prolonged the susceptibility of wounds to infection from nine to 16 days, suggesting that the risks associated with drains may outweigh their benefits, highlighting a lack of consensus among surgeons regarding their necessity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Israeli Study of Surgical Infection of drains and the risk of wound infection in operations for hernia. Simchen, E., Rozin, R., Wax, Y.[2011]

In a study of 210 patients who underwent vascular surgery, the use of closed suction drains (CSDs) in groin wounds was associated with a higher rate of surgical site infections (SSI) at 14% compared to 5.6% in those without drains; however, this difference was not significant after adjusting for confounding factors like smoking and diabetes.

Patients with CSDs experienced lower rates of reintervention (37.5% vs. 69%) and shorter hospital stays (7 days vs. 22 days), suggesting that CSDs may improve postoperative outcomes despite the initial higher SSI rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Closed Suction Drains in Groin Incisions after Femoral Artery Exposure. Manzur-Pineda, K., Bornak, A., Montoya, C., et al.[2023]

A new randomized trial with 60 participants found that preoperative washing with antiseptics like chlorhexidine gluconate and octenidine significantly reduced bacterial colony forming units (CFUs) compared to regular soap, particularly in the underarm and groin areas.

Current national guidelines against preoperative body washing may be outdated, as this study suggests that modern antiseptic methods could be more effective in preventing surgical site infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fresh look at preoperative body washing. Tanner, J., Gould, D., Jenkins, P., et al.[2021]

In a study of 100 patients undergoing breast surgery, local antiseptic interventions significantly reduced bacterial colonization of surgical drains, with only 21% of antisepsis drains showing positive cultures compared to 66% in the control group.

While the reduction in bacterial colonization did not lead to a statistically significant difference in surgical site infections (6% in control vs. 2% in antisepsis), the results suggest that further research on antiseptic methods could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations. Degnim, AC., Scow, JS., Hoskin, TL., et al.[2022]

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