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

Trial Summary

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.

What data supports the effectiveness of the treatment Delayed Bathing, Traditional Bathing, Covered Wound Bathing, Early Bathing, Early Postoperative Bathing, Immediate Post-Surgical Bathing for surgical wounds?

Research suggests that early postoperative bathing can improve patient satisfaction and may help with early movement, which is beneficial after surgery. However, the impact on infection rates is unclear, and early washing might disturb the healing environment. ^{1 2 3 4 5}

Is it safe to bathe or shower after surgery before stitches are removed?

Research shows that allowing patients to shower or bathe before stitches are removed does not increase the risk of infection compared to keeping the surgical site dry. Early bathing can also help with patient satisfaction and early movement, which is beneficial after surgery. ^{1 2 4 5 6}

How does the timing of postoperative bathing affect surgical wound healing?

The timing of postoperative bathing, whether early or delayed, can influence surgical wound healing by affecting factors like patient mobility and wound cleanliness. Early bathing may promote quicker patient movement and reduce sweat and dirt buildup, but it could also risk irritating the wound and disrupting the healing process. Conversely, delaying bathing might help protect the wound environment initially but could lead to discomfort and hygiene issues. ^{1 2 4 5 7}

What is the purpose of this trial?

This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds. Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.

Research Team

William M Ricci, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

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

Early versus delayed post-operative bathing or showering to prevent wound complications. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Does the timing of postoperative showering impact infection rates? A systematic review and meta-analysis. [2020]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Early versus delayed post-operative bathing or showering to prevent wound complications. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Influence of early postoperative showering in undressed surgical wound for better clinical outcome. [2021]

6. 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]

7. Greece 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. [2023]