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).
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.
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.
- Conditions
- Surgical Wound Infection
- 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 group | Role | What they receive |
|---|---|---|
| Shower Group | Experimental | Patients who had a shower in 48-72 hours after Median Sternotomy Receives: Other: postoperative early shower |
| Control Group | Active comparator | Patients 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.
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)
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.
- First posted31 Jan 2020
- Study start21 Dec 2016
- Primary completion30 Sep 2017
- Study completion24 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Gök, Pamukkale University
- Investigators
- Fatma Demir Korkmaz, RN, PhD, Study director, ege university, faculty of nursingBilgin Emrecan, Study chair, Pamukkale University
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pamukkale University Medical Faculty
- ClinicalTrials.gov ID
- NCT04250961
- Acronym / sponsor ID
- 60116787-020/24129
- Conditions
- Surgical Wound Infection
- Keywords
- cardiac surgery, pain, patient comfort, satisfaction, showering, wound infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 24 Dec 2017 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Prospective, Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Shower Group | Experimental | Other: postoperative early showerPatients who had a shower in 48-72 hours after Median Sternotomy |
| Control Group | Active comparator | Other: postoperative early showerPatients whose sternal incision site was not connected water until remove sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Having reoperation,
- Having the chest tube until 72 hours after surgery,
- Developed complications including cardiac tamponade, pleural effusion and pneumonia after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative early showerThe shower group showered in 48-72 hours after median sternotomy with tap water. | Other | Control Group, Shower Group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Derived from this study: PubMed 33871023Gok 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Demir Korkmaz, RN, PhD study director
ege university, faculty of nursing
Bilgin Emrecan study chair
Pamukkale University
1 site in 1 country: see every site and its status.
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.