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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250961
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Fadime Gök, Pamukkale University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Surgical Wound Infection Other: postoperative early shower Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Prospective, Randomized Controlled Trial
Masking: Single (Participant)
Masking Description: All results (wound culture and photographs) were sent to an Infection Control Committee who was masked as to the patient grouping for evaluation.
Primary Purpose: Prevention
Official Title: Pamukkale University Medical Faculty
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : December 24, 2017

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Arm Intervention/treatment
Experimental: Shower Group
Patients who had a shower in 48-72 hours after Median Sternotomy
Other: postoperative early shower
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
Other: postoperative early shower
The shower group showered in 48-72 hours after median sternotomy with tap water.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250961


Locations
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Turkey
Fadime Gök
Denizli, Turkey, 20100
Sponsors and Collaborators
Pamukkale University
Investigators
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Study Director: Fatma Demir Korkmaz, RN, PhD ege university, faculty of nursing
Study Chair: Bilgin Emrecan pamukkale university, faculty of medicine
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Responsible Party: Fadime Gök, Faculty of Health Sciences, Department of Surgical Disease Nursing, Pamukkale University
ClinicalTrials.gov Identifier: NCT04250961    
Other Study ID Numbers: 60116787-020/24129
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fadime Gök, Pamukkale University:
cardiac surgery
pain
patient comfort
satisfaction
showering
wound infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Surgical Wound
Wounds and Injuries
Postoperative Complications
Pathologic Processes