Early vs Delayed Bathing for Surgical Wounds

(EVDB Trial)

Overseen By Craig E Klinger, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Infection, Multiple fractures, Immune compromise, Diabetes, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether early or delayed showering after surgery for broken bones promotes better wound healing. It compares two groups: one begins gentle showering on day three after surgery (Early Bathing), while the other starts after 10 to 20 days, once stitches are removed (Delayed Bathing). The trial seeks to determine which approach aids wound healing more effectively. Ideal participants are adults with simple fractures in their arms or legs, without other health issues such as diabetes or infections. As an unphased trial, this study allows participants to contribute to enhancing post-surgical care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that bathing soon after surgery is safe. Studies have found that early bathing does not increase the risk of wound infections compared to waiting longer. In fact, some research suggests that not bathing for a few days can lead to a build-up of sweat and dirt, which might hinder healing.

Both early and delayed bathing have been studied, and neither increases the chance of wound problems. This indicates that both options are generally safe. Therefore, whether one chooses to bathe soon or wait, there should be little concern about wound infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing early versus delayed bathing for surgical wounds because it challenges the traditional post-surgery care routine. Typically, patients are advised to keep surgical wounds dry until sutures are removed, which can take 10 to 20 days. This trial investigates if early bathing, starting just three days after surgery, could be safe and possibly even beneficial. If early bathing proves effective, it could simplify recovery, improve patient comfort, and reduce the risk of infection by promoting better hygiene sooner. Finding out whether early bathing is advantageous could lead to a significant shift in post-operative care practices, making recovery more convenient for patients.

What evidence suggests that early or delayed bathing is effective for surgical wound care?

This trial will compare early and delayed bathing for surgical wounds. Research has shown that showering soon after surgery doesn't increase the risk of wound infections. Participants in the early bathing group will begin showering with body soap on postoperative day 3, while those in the delayed bathing group will start after wound examination and suture removal (10-20 days postoperative). Studies have found that washing the body just a few days after surgery is as safe as waiting longer. Not showering for too long can lead to a buildup of sweat and dirt, which isn't ideal. Some evidence suggests that early bathing might cause slight irritation, but it doesn't seem to increase infection risk. Overall, both early and delayed bathing have similar effects on wound safety. ^{1 3 6 7 8}

Who Is on the Research Team?

William M Ricci, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for adults over 18 with fresh fractures in arms or legs (like the humerus, radius, ulna, femur, tibia, or fibula) that need surgery but don't need a splint afterward. Pregnant individuals and those with complicated wounds aren't eligible.

Inclusion Criteria

I have a broken bone that needs surgery.

I had a fracture that didn't need a splint after surgery.

I have a recent single fracture in my arm or leg.

Exclusion Criteria

I have had multiple fractures.

Patient homeless

I have a fracture that is thought to be caused by an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to early or delayed bathing post-surgery

12 weeks

3 visits (in-person) at weeks 2, 6, and 12

Follow-up

Participants are monitored for patient satisfaction and infection rates

12 weeks

3 visits (in-person) at weeks 2, 6, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Delayed Bathing
• Early Bathing

Trial Overview The study compares two ways of caring for surgical wounds after orthopaedic surgery: Group A will start showering early without covering their wounds while Group B will wait longer before bathing and keep their wounds covered.

How Is the Trial Designed?

Group I: Delayed Bathing Active Control 1 Intervention

Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).

Group II: Early Bathing Active Control 1 Intervention

Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

New York Presbyterian Hospital

Collaborator

Trials

77

Recruited

57,300+

Published Research Related to This Trial

Allowing patients to take a tap water body bath 24 hours after surgery, while keeping wounds undressed, did not increase the risk of surgical site infections compared to traditional methods of keeping wounds dry until suture removal.

The study found that early mobilization and maintaining a moist environment for surgical wounds significantly reduced the incidence of infections in various types of surgeries, suggesting these practices can enhance postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of early postoperative showering in undressed surgical wound for better clinical outcome. Jayathilake, A., Jayaweera, JAAS., Kumbukgolla, WW., et al.[2021]

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 meta-analysis of 10 randomized controlled trials involving 1,708 participants, early removal of surgical dressings was associated with a better patient perception of safety and comfort, although these findings were not statistically significant for most outcomes.

Overall, the study concluded that delayed dressing removal is not superior to early removal for managing clean or clean-contaminated surgical wounds, suggesting that early removal may be a viable option without increasing infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of early and delayed removal of dressing following primary closure of clean and contaminated surgical wounds: A systematic review and meta-analysis of randomized controlled trials. Zhang, T., Zhang, F., Chen, Z., et al.[2023]

A systematic review identified only one high-risk bias trial involving 857 patients that compared early post-operative bathing (within 12 hours) to delayed bathing (after 48 hours), finding no significant difference in surgical site infections (SSIs) between the two groups (8.5% vs 8.8%).

Due to the lack of conclusive evidence and the wide confidence intervals, the study suggests that further randomized controlled trials are necessary to determine the safety and efficacy of early versus delayed post-operative bathing for preventing wound complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus delayed post-operative bathing or showering to prevent wound complications. Toon, CD., Sinha, S., Davidson, BR., et al.[2022]

A systematic review identified only one high-risk bias trial involving 857 patients that compared early post-operative bathing (within 12 hours) to delayed bathing (after 48 hours), finding no significant difference in surgical site infections (SSIs) between the two groups (8.5% vs 8.8%).

Due to the lack of conclusive evidence and the wide confidence intervals, the study suggests that further randomized controlled trials are needed to better understand the impact of early versus delayed post-operative bathing on wound healing and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus delayed post-operative bathing or showering to prevent wound complications. Toon, CD., Sinha, S., Davidson, BR., et al.[2021]

The use of a novel apparatus that delivers pulsating liquid spurts for bathing surgical wounds significantly reduces the risk of infection, decreasing primary dissemination by 1000 times without causing tissue trauma.

In a clinical study involving 384 abdominal surgeries, this prophylactic method led to over a 5-fold reduction in wound complications and shortened hospitalization times after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prospects and possibilities of prophylactic washing of surgical wounds by pulsating spurs of liquid under pressure]. Volenko, AV.[2010]

A systematic review and meta-analysis of 12 studies involving 2,839 patients found no significant difference in infection or complication rates between patients who showered within the first 48 hours after surgery and those who showered later.

Allowing early postoperative showering does not increase the risk of wound infections or complications, suggesting that patient satisfaction can be improved without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the timing of postoperative showering impact infection rates? A systematic review and meta-analysis. Copeland-Halperin, LR., Reategui Via Y Rada, ML., Levy, J., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7092546/

Early versus delayed post‐operative bathing or showering to ... Avoiding post‐operative bathing or showering for two to three days may result in accumulation of sweat and dirt on the body.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11195341/

Does earlier bathing increase the risk of surgical site infection ... Studies have found that earlier postoperative bathing does not increase the risk of suturing wound infection compared with bandaging without bathing.

3. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010075.pub2/abstract

Early versus delayed post‐operative bathing or showering ... Avoiding post‐operative bathing or showering for two to three days may result in accumulation of sweat and dirt on the body. Conversely, early ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606018300291

Infection The gap between currently available evidence ... delayed showering protocols. Published literature demonstrates no increase in the overall rate of wound infections or complications when patients showered ...

5. researchgate.net researchgate.net/publication/381124425_Does_earlier_bathing_increase_the_risk_of_surgical_site_infection_A_meta-analysis_of_11_randomized_controlled_trials

Does earlier bathing increase the risk of surgical site ... The incidence of wound infection did not differ significantly between the earlier bathing and delayed bathing groups, nor did rates of other ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26204454/

Early versus delayed post-operative bathing or showering ... Avoiding post-operative bathing or showering for two to three days may result in accumulation of sweat and dirt on the body. Conversely, early ...

7. researchgate.net researchgate.net/publication/257755156_Early_versus_delayed_post-operative_bathing_or_showering_to_prevent_wound_complications

Early versus delayed post-operative bathing or showering ... Avoiding post-operative bathing or showering for two to three days may result in accumulation of sweat and dirt on the body. Conversely, early washing of the ...

8. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010075.pub2/related-content

Early versus delayed post‐operative bathing or showering ... Early versus delayed post‐operative bathing or showering to prevent wound complications · Preoperative bathing or showering with skin antiseptics ...