Comparison of the Classical Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision

NCT06725472 | Completed

• 1 other identifier: TSA-2023-13179
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Incision; Surgical Site Infection; Keloid Scar Following Surgery

Keywords

open heart surgery; median sternotomy; flap skin incision

Outcome Measures

Primary Outcomes (1)

• Determination of the effectiveness of paramedian flap skin incision technique.

  Observation of wound epithelization and healing process.

  1 week, 3 month

Secondary Outcomes (1)

• Surgical wound infection development

  1 week, 3 month

Study Arms (2)

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.

Procedure: Open Heart Surgery

Control group

Patients undergoing open heart surgery with median sternotomy undergo a classical skin incision on the medium of the sternum.

Procedure: Open Heart Surgery

Interventions

Open Heart Surgery PROCEDURE

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; Paramedian flap skin incision group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: December 10, 2024
• Study Start: December 21, 2023
• Primary Completion: June 24, 2024
• Study Completion: July 10, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-07

Locations

TU (1)