AzTrials
AzTrials

Surgical Wound InfectionNCT04250961

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

A study testing postoperative early shower in people with Surgical Wound Infection, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgical Wound Infection
What is being tested?
postoperative early shower
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Dec 2016to 24 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Fadime Gök

    Denizli, 20100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
postoperative early shower
Keywords
cardiac surgery, pain, patient comfort, satisfaction, showering, wound infection
Medical subject headings
Surgical Wound Infection, Pain, Personal Satisfaction, Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • postoperative early showerOther

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

Study groups in NCT04250961
Study groupRoleWhat they receive
Shower GroupExperimentalPatients who had a shower in 48-72 hours after Median Sternotomy
Receives: Other: postoperative early shower
Control GroupActive comparatorPatients whose sternal incision site was not connected water until remove sutures
Receives: Other: postoperative early shower

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sternotomy on Wound Infection

    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.

    Measured: 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 outcomes (1)
  1. The secondary outcomes included sternal wound pain score

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start21 Dec 2016
  3. Primary completion30 Sep 2017
  4. Study completion24 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Prospective, Randomized Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04250961
Sponsor's protocol ID
60116787-020/24129
Status last verified
Sep 2020
First submitted
24 Jan 2020
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33871023

Questions about this trial

What is this clinical trial studying?

A study testing postoperative early shower in people with Surgical Wound Infection, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04250961, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in