Clinical trial NCT06725472: Comparison of the Classical Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision
Official title: Comparison of the Classic Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision Technique in Open Heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Incision
Surgical Site Infection
Keloid Scar Following Surgery
Keywords: open heart surgery
median sternotomy
flap skin incision
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients who underwent open heart surgery through a classic median sternotomy at a six-month period were randomized to receive a classic median skin incision and a paramedian flap skin incision.

Brief summary: The goal of this observational study is to determine the effects of a flap-shaped paramedian skin incision on protection from mediastinal infections, wound healing, and scar formation in open heart surgery performed through the classic median sternotomy approach compared with the classic median skin incision. The main question aimed to be answered is:

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: Median sternotomy (MS) is the classic opening technique for open heart surgery. The skin incision is made in line with the bone incision at the center of the sternum. The paramedian flap skin incision involves making a skin incision approximately 2-3 cm lateral to the sternal bone incision, then lifting the skin as a flap using subcutaneous tissue. The investigators aim to determine the efficacy of the paramedian flap skin incision by comparing it with the classic median skin incision, considering that this flap-style incision may result in faster wound healing and better protection against infections.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective open heart surgery via median sternotomy.
* Age range: Over 18 and under 80 years of age.

Exclusion Criteria:

* Who do not accept informed consent,
* 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.

Primary outcomes:
measure: Determination of the effectiveness of paramedian flap skin incision technique.
timeFrame: 1 week, 3 month
Secondary outcomes:
measure: Surgical wound infection development
timeFrame: 1 week, 3 month
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References: