Effects of Showering in 48-72 Hours of Median Sternotomy on Wound Infection, Pain, Comfort and Satisfaction

NCT ID: NCT04250961

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-21

Study Completion Date

2017-12-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Time of showering after surgery is still a controversial issue for surgical patients and health professionals. It has been reported that patients should not shower until sutures are removed since traditionally showering is thought to cause infections after surgery. However, not showering after surgery not only has a negative effect on patient comfort but also brings about the risk of infections.

Sternal wound infections after coronary artery bypass graft surgery through median sternotomy are one of the important, life-threatening complications. For this reasons, the investigators researched the advantages and disadvantages of showering for postoperative sternal wound infections, pain due to sternotomy and patient comfort and satisfaction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sternal wound infections after coronary artery bypass graft surgery through median sternotomy are one of the important, life-threatening complications increasing length of hospital stay, morbidity and mortality and difficult to treat. In addition to adopting asepsis and antisepsis, meeting hygiene needs, an important nursing intervention, plays a role in prevention of sternal wound infections.

Showering is an important hygiene practice. It has been reported that patients should not shower until sutures are removed since traditionally showering is thought to cause infections after surgery. However, not showering after surgery not only has a negative effect on patient comfort but also brings about the risk of infections. Guidelines for prevention of surgical site infections do not involve recommendations about early showering after surgery or keeping surgical wounds closed and dry for a long time after surgery.

In recent years, it has been reported that keeping postsurgical wounds closed and dry is unnecessary and that showering before removal of sutures is not harmful. There have been studies which reveal showering early after surgery does not increase the risk of infections, even decreases pain and has a positive influence on patient comfort and satisfaction. It is thought that postsurgical showering can quicken wound healing by cleaning sweat, dirt, microorganisms and debris and thus can reduce the risk of infections. However, at present, whether showering before removal of sutures affects wound healing is debatable. Despite presence of studies about effects of postsurgical showering on wound healing, there have not been any studies on the impact of showering after CABG surgery through median sternotomy. Lack of evidence about this issue causes difficulty in relevant nursing practices.

The present study was performed to evaluate effects of showering in 48-72 hours after median sternotomy on sternal wound infections, sternotomy related pain and patient comfort and satisfaction.

MATERIALS AND METHODS Study Design and Setting This is a randomized controlled study carried out to evaluate effects of showering in 48-72 hours after median sternotomy on sternal wound infections, pain due to sternotomy and patient comfort and satisfaction. The study was conducted in the cardiovascular surgery clinic with 30 beds at a university hospital in Aegean region, Turkey, between 21 December 2016 and 30 September 2017.

Inclusion and Exclusion Criteria Inclusion criteria were age of over 18 years, having CABG surgery through median sternotomy, removal of the chest tube, having sutures in place and accepting to participate in the study. Exclusion criteria were having reoperation, removal of the chest tube 72 hours after surgery, developing complications including cardiac tamponade, pleural effusion and pneumonia after surgery and going to another hospital for follow-up.

The sample size was based on a power analysis made with PS Software Version 3.0.43.17 Since there was not a study about effects of showering in the early postoperative period after sternotomy, the power of the study based on the mean effect size (alpha=0.50), the confidence interval (CI) of 95% and the significance level of P \< .05 was determined as 80%.18 The sample size was found to be 50 patients, of whom 25 assigned the intervention group (shower group) and other assigned the control group. Taking account of possible losses, a higher number of subjects at the rate of 20% was planned to include in the study. As a result, each group included 30 subjects. However, four patients, of whom one decided not to shower, one developed sternal instability, one died of aspiration pneumonia on the tenth day of surgery and one went to another hospital for follow-up, were excluded from the shower group. Five patients, of whom one had reoperation on the 13th day due to cardiac tamponade, one died of cardiopulmonary arrest on the 14th day and three went to another hospital for postoperative follow-up, were excluded from the control group. The study was completed with 51 patients, of whom 26 were in the shower group and 25 were in the control group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Prospective, Randomized Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
All results (wound culture and photographs) were sent to an Infection Control Committee who was masked as to the patient grouping for evaluation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Shower Group

Patients who had a shower in 48-72 hours after Median Sternotomy

Group Type EXPERIMENTAL

postoperative early shower

Intervention Type OTHER

The shower group showered in 48-72 hours after median sternotomy with tap water.

Control Group

Patients whose sternal incision site was not connected water until remove sutures

Group Type ACTIVE_COMPARATOR

postoperative early shower

Intervention Type OTHER

The shower group showered in 48-72 hours after median sternotomy with tap water.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

postoperative early shower

The shower group showered in 48-72 hours after median sternotomy with tap water.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years age and older ,
* Having CABG surgery through median sternotomy,
* Removed the chest tube,
* Must be followed up the same hospital
* Accepting to participate in the study

Exclusion Criteria

* Having reoperation,
* Having the chest tube until 72 hours after surgery,
* Developed complications including cardiac tamponade, pleural effusion and pneumonia after surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fadime Gök

Faculty of Health Sciences, Department of Surgical Disease Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fatma Demir Korkmaz, RN, PhD

Role: STUDY_DIRECTOR

ege university, faculty of nursing

Bilgin Emrecan

Role: STUDY_CHAIR

Pamukkale University Faculty of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fadime Gök

Denizli, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Gok F, Demir Korkmaz F, Emrecan B. 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. Eur J Cardiovasc Nurs. 2022 Jan 11;21(1):56-66. doi: 10.1093/eurjcn/zvab010.

Reference Type DERIVED
PMID: 33871023 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

60116787-020/24129

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.