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

NCT04250961 | Completed DMC

• 1 other identifier: 60116787-020/24129
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Infection

Keywords

cardiac surgery; pain; patient comfort; satisfaction; showering; wound infection

Outcome Measures

Primary Outcomes (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.

  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

  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 Outcomes (1)

• Other outcome, patients comfort and satisfaction

  patients comfort and satisfaction evaluated by the researcher within 48-72 hours after surgery (before and after showering).

Study Arms (2)

Shower Group

EXPERIMENTAL

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

Other: postoperative early shower

Control Group

ACTIVE COMPARATOR

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

Other: postoperative early shower

Interventions

postoperative early shower OTHER

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

Control Group; Shower Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Fadime Gök

Denizli, 20100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33871023 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Pain; Personal Satisfaction; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Fatma Demir Korkmaz, RN, PhD

  ege university, faculty of nursing

  STUDY DIRECTOR

• Bilgin Emrecan

  Pamukkale University Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All results (wound culture and photographs) were sent to an Infection Control Committee who was masked as to the patient grouping for evaluation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Health Sciences, Department of Surgical Disease Nursing

Model Details: A Prospective, Randomized Controlled Trial

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 31, 2020
• Study Start: December 21, 2016
• Primary Completion: September 30, 2017
• Study Completion: December 24, 2017
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)