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

Trial Summary

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 data supports the effectiveness of the treatment Restriction of Showering, Showering for reducing surgical site infection risk?

Research suggests that early daily showering after foot and ankle surgery does not significantly increase the risk of infection, indicating that showering may be safe post-surgery. Additionally, preoperative showers with antiseptics like chlorhexidine have been shown to reduce skin bacteria, although their impact on infection rates is less clear. ^{1 2 3 4 5}

Is it safe to shower with surgical drains?

Postoperative showering for patients with closed suction drainage is safe and does not increase the risk of complications, including surgical site infection, according to a study on breast reconstruction patients. ^{6 7 8 9 10}

How does showering with drains differ from other treatments for surgical site infection risk?

Showering with drains is unique because it allows patients to maintain normal hygiene by showering even with surgical drains in place, without increasing the risk of infection. This approach contrasts with traditional practices that often restrict water contact with surgical sites until sutures are removed, aiming to prevent infection. ^{6 7 10 11 12}

What is the purpose of this trial?

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.

Research Team

Sean Devitt, MD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Rationalizing whole body disinfection. [2019]

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

A fresh look at preoperative body washing. [2021]

3. United States 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. [2014]

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

Influence of povidone-iodine preoperative showers on skin colonization in elective plastic surgery procedures. [2022]

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

Randomized controlled trial of the effectiveness of chlorhexidine showers before elective plastic surgical procedures. [2015]

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

The Israeli Study of Surgical Infection of drains and the risk of wound infection in operations for hernia. [2011]

7. United States 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. [2022]

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

Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Utility of Closed Suction Drains in Groin Incisions after Femoral Artery Exposure. [2023]

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

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

11. Germany pubmed.ncbi.nlm.nih.gov

[Postoperative wound healing in wound-water contact]. [2013]

12. United States 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. [2018]