Early Showering After Surgery for Breast Reconstruction Recovery

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Existing wounds, Previous infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

100 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.

What data supports the effectiveness of the treatment of early showering after surgery for breast reconstruction recovery?

Research shows that early showering after surgery, even with drains, is safe and does not increase the risk of complications like infections. Patients who showered early reported similar satisfaction and comfort levels compared to those who waited longer. ^{1 2 3 4 5}

Is early showering after surgery generally safe for humans?

Research indicates that early postoperative showering is generally safe and does not increase the risk of complications, such as infections, even for patients with drainage tubes after breast reconstruction surgery. ^{1 5 6 7 8}

How does early showering after breast reconstruction surgery differ from other treatments?

Early showering after breast reconstruction surgery is unique because it allows patients to shower soon after surgery, even with drainage tubes in place, without increasing the risk of complications. This approach contrasts with traditional practices that often delay showering until all drains are removed, providing a more comfortable and potentially quicker recovery experience. ^{1 2 5 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection. The main questions it aims to answer are: * Is there an increased risk of infection/complications with showering 48 hours after drain tubes are in place * Does showering after 48 hours with drain tubes in place affect quality of life.

Eligibility Criteria

This trial is for individuals over 18 years old who are undergoing breast surgery with tissue expanders and drains. Participants must be willing to follow the study's procedures.

Inclusion Criteria

Acceptance of protocol and procedures

I am having breast surgery with a tissue expander and drains.

I am older than 18 years.

Exclusion Criteria

I currently have wounds.

History of previous infections related to implant device if delayed

I have chosen not to participate in certain treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either shower daily after 48 hours with drains in place or wait until drains are removed before showering

90 days

Regular post-operative evaluations

Follow-up

Participants are monitored for signs of infection and complete a quality of life survey

90 days

Post-operative evaluations and survey completion

Treatment Details

Interventions

• Showering 48 hours after surgery

Trial Overview The study is testing if showering 48 hours after breast reconstruction surgery with drain tubes in place affects infection rates or quality of life.

Participant Groups

Group I: Showering 48 hours after Surgery Experimental Treatment 1 Intervention

Group 1 will be allowed to shower 48 hours after surgery with drain tubes still in place.

Group II: Showering after drain tubes are removed Active Control 1 Intervention

Group 2 will not be allowed to shower until drain tubes are removed.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Findings from Research

A study of 100 cardiac surgery patients found that early postoperative showers, initiated an average of 6 days after surgery, did not lead to any wound complications such as infections or dehiscence.

Patient satisfaction was high, with an average score of 7.4 out of 10, suggesting that early showers are well-received and can be safely implemented after cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of early postoperative shower after cardiac surgery. Yoo, JS., Lee, H., Kim, SE., et al.[2022]

In a study of 187 breast cancer patients, the 20 mL drain removal strategy resulted in the best balance of drain duration and quality of life, particularly in physical and role functioning at 2 and 3 weeks post-surgery.

The 20 mL group had a lower incidence of seroma compared to the 30 mL group, suggesting that this strategy may reduce complications while maintaining similar healthcare costs and postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Optimal Strategy for Drain Removal After Mastectomy and Axillary Surgery in Breast Cancer Patients? A Multicenter, Three-Arm Randomized Clinical Trial. Wen, N., Ouyang, C., Hu, X., et al.[2022]

In a study of 51 patients who underwent median sternotomy, those who showered within 48-72 hours post-surgery had a significantly lower rate of sternal wound infections (7.7%) compared to those who did not shower (32.0%).

Patients who showered reported less pain and higher levels of comfort and satisfaction, indicating that early post-operative showering can improve overall recovery experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of showering in 48-72 h after coronary artery bypass graft surgery through median sternotomy on wound infection, pain, comfort, and satisfaction: randomized controlled trial. Gök, F., Demir Korkmaz, F., Emrecan, B.[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]

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 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]

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]

In a study of 569 patients undergoing prosthesis-based breast reconstruction, the duration of drain placement was found to significantly impact infection rates, with a 76.2% increase in infection risk for each additional week the drain was retained beyond 21 days.

The study concluded that drains should ideally be removed no later than 3 weeks post-surgery, and can be safely removed as early as 7 days post-operation, regardless of daily drainage volumes exceeding 30 mL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of infection is associated more with drain duration than daily drainage volume in prosthesis-based breast reconstruction: A cohort study. Chen, CF., Lin, SF., Hung, CF., et al.[2022]

In a study of 149 patients undergoing microvascular breast reconstruction, the average duration for breast and abdominal drains was found to be 12.9 days and 17.7 days, respectively, with prolonged use defined as beyond 14 days for breast drains and 19 days for abdominal drains.

Factors such as elevated BMI, hypertension, axillary dissection, and certain racial backgrounds (African-American and Hispanic) were associated with longer breast drain durations, highlighting the need for tailored post-operative care for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors for Prolonged Drain Use Following Autologous Breast Reconstruction. Dinis, J., Allam, O., Junn, A., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

Effects of early postoperative shower after cardiac surgery. [2022]

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

What Is the Optimal Strategy for Drain Removal After Mastectomy and Axillary Surgery in Breast Cancer Patients? A Multicenter, Three-Arm Randomized Clinical Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effects of showering in 48-72 h after coronary artery bypass graft surgery through median sternotomy on wound infection, pain, comfort, and satisfaction: randomized controlled trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

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

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

Risk of infection is associated more with drain duration than daily drainage volume in prosthesis-based breast reconstruction: A cohort study. [2022]

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

Predictors for Prolonged Drain Use Following Autologous Breast Reconstruction. [2022]