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

September 17, 2020 updated by: Fadime Gök, Pamukkale University

Pamukkale University Medical Faculty

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Denizli, Turkey, 20100
        • Fadime Gök

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shower Group
Patients who had a shower in 48-72 hours after Median Sternotomy
The shower group showered in 48-72 hours after median sternotomy with tap water.
Active Comparator: Control Group
Patients whose sternal incision site was not connected water until remove sutures
The shower group showered in 48-72 hours after median sternotomy with tap water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sternotomy on Wound Infection
Time Frame: Symptoms of infection determinated 24 hours after surgery, within 48-72 hours after surgery, up to day 7 post surgery, day 14 post surgery and one month after surgery
The primary outcome measure was the rate of sternal wound infection. Sternal wound infection was defined as the presence of redness and swelling, or the presence of a purulent exudate or a positive bacterial culture.
Symptoms of infection determinated 24 hours after surgery, within 48-72 hours after surgery, up to day 7 post surgery, day 14 post surgery and one month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcomes included sternal wound pain score
Time Frame: wound pain score evaluated within 48-72 hours after surgery (before and after showering), up to day 7 post surgery and day 14 post surgery.
sternal wound pain score evaluated with visual analog scale. It consists of a vertical or horizontal scale on a 10-cm line, with the 0 cm point corresponding to no pain and 10 cm corresponding to the worst pain.
wound pain score evaluated within 48-72 hours after surgery (before and after showering), up to day 7 post surgery and day 14 post surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other outcome, patients comfort and satisfaction
Time Frame: patients comfort and satisfaction evaluated by the researcher within 48-72 hours after surgery (before and after showering).
patients comfort and satisfaction evaluated with using a visual analog scale. It consists of a vertical or horizontal scale on a 10-cm line, with the 0 cm point corresponding to worst comfort and satisfaction and 10 cm corresponding to the best comfort and satisfaction.
patients comfort and satisfaction evaluated by the researcher within 48-72 hours after surgery (before and after showering).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Fatma Demir Korkmaz, RN, PhD, ege university, faculty of nursing
  • Study Chair: Bilgin Emrecan, Pamukkale University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

December 24, 2017

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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