Comparison of the Classical Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision
NCT ID: NCT06725472
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2023-12-21
2024-07-10
Brief Summary
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Is paramedian flap skin incision effective in improving sternotomy wound healing? Does it have a preventive effect on the development of sternal wound infection? Does it have a protective effect on keloid formation? Patients who underwent open-heart surgery with classical median sternotomy will be randomized into two groups: paramedian flap skin incision and median skin incision. The effectiveness of the paramedian incision will be investigated by comparing perioperative data and data from the first three months of follow-up.
Detailed Description
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In a six-month period, 90 consecutive patients who underwent open heart surgery with classic median sternotomy in the Cardiovascular Surgery Clinic will be randomized into two groups: classic median skin incision and paramedian flap skin incision. The investigators will prospectively record data from 45 individuals in both groups and will follow them up at the first week, first month, and third month after discharge. During the follow-ups, physical examinations will be performed, wound sites and sternal bone healing processes will be evaluated, and infection status will be checked through radiologic and laboratory examinations.
Surgical Technique
Classic Median Sternotomy Skin Incision:
After the anesthesia procedures are completed in the supine position, under general anesthesia, following skin disinfection and sterile dressing, a longitudinal skin incision is made in the midline of the sternum from the jugulum to the xiphoid. Subcutaneous hemorrhages are cauterized, the periosteum is scratched in the midline with electrocautery, and a sternotomy is performed with a sternum saw, after which open heart surgery procedures are continued. In closure, after the sternum is closed, the subcutaneous tissue is first closed with the continuous suture technique, and then the skin is closed.
Para-Median Flap Skin Incision:
After the anesthesia procedures are completed in the supine position, under general anesthesia, following skin disinfection and sterile dressing, the midline of the sternum is determined. A crescent-shaped paramedian skin incision is made on the right or left side from the jugulum to the xiphoid. The subcutaneous tissue is carefully separated and opened as a flap with a dissector. Bleeding is stopped with pressure if possible, and the use of electrocautery is minimized. The periosteum is incised down to the sternal bone tissue, and the midline of the sternum is drawn with electrocautery. A sternotomy is performed, and open heart surgery procedures are continued. After the sternum is closed, the flap ends are first joined subcutaneously to ensure that the skin incision is away from the bone incision.
Data Analysis:
Demographic data of the individuals, as well as preoperative, postoperative, and follow-up data, will be recorded and analyzed using the SPSS statistical program.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Paramedian flap skin incision group
Patients undergoing open heart surgery with median sternotomy undergo a skin incision 2-3 cm lateral to the sternum's medium.
Open Heart Surgery
This is a general term for surgical procedures that directly access the heart through an opening in the chest to treat heart problems.
Control group
Patients undergoing open heart surgery with median sternotomy undergo a classical skin incision on the medium of the sternum.
Open Heart Surgery
This is a general term for surgical procedures that directly access the heart through an opening in the chest to treat heart problems.
Interventions
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Open Heart Surgery
This is a general term for surgical procedures that directly access the heart through an opening in the chest to treat heart problems.
Eligibility Criteria
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Inclusion Criteria
* Age range: Over 18 and under 80 years of age.
Exclusion Criteria
* Failure to show up for necessary check-ups,
* Emergency surgery (not elective emergencies),
* Patients with exitus in the hospital in the postoperative period and during the 3-month follow-up period.
18 Years
80 Years
ALL
No
Sponsors
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Ataturk University
OTHER
Responsible Party
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Eyüpserhat ÇALIK
Associate Professor
Locations
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Ataturk University
Erzurum, , Turkey (Türkiye)
Countries
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Other Identifiers
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TSA-2023-13179
Identifier Type: -
Identifier Source: org_study_id