Surgical IncisionNCT06725472
Comparison of the Classical Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision
An observational study of Surgical Incision and Surgical Site Infection, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Incision, Surgical Site Infection, Keloid Scar Following Surgery
- What is being tested?
- Open Heart Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2023to 10 Jul 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing elective open heart surgery via median sternotomy.
- Age range: Over 18 and under 80 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Classic Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision Technique in Open Heart Surgery
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.
Read the 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.
- Being tested
- Open Heart Surgery
- Keywords
- open heart surgery, median sternotomy, flap skin incision
- Medical subject headings
- Surgical Wound, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Heart SurgeryProcedure or surgery
This is a general term for surgical procedures that directly access the heart through an opening in the chest to treat heart problems.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Open Heart Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the effectiveness of paramedian flap skin incision technique.
Observation of wound epithelization and healing process.
Measured: 1 week, 3 month
Secondary outcomes (1)
Surgical wound infection development
A sternal wound infection was defined as conditions ranging from any non-hemorrhagic discharge to a deep sternal infection.
Measured: 1 week, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start21 Dec 2023
- Primary completion24 Jun 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyüpserhat ÇALIK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725472
- Sponsor's protocol ID
- TSA-2023-13179
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Classic Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision Technique in Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06725472
- Acronym / sponsor ID
- TSA-2023-13179
- Keywords
- open heart surgery, median sternotomy, flap skin incision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paramedian flap skin incision group | – | Procedure: Open Heart SurgeryPatients undergoing open heart surgery with median sternotomy undergo a skin incision 2-3 cm lateral to the sternum's medium. |
| Control group | – | Procedure: Open Heart SurgeryPatients undergoing open heart surgery with median sternotomy undergo a classical skin incision on the medium of the sternum. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing elective open heart surgery via median sternotomy.
- Age range: Over 18 and under 80 years of age.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Heart SurgeryThis is a general term for surgical procedures that directly access the heart through an opening in the chest to treat heart problems. | Procedure or surgery | Control group, Paramedian flap skin incision group |
Primary outcome
Determination of the effectiveness of paramedian flap skin incision technique.
Time frame: 1 week, 3 month
Observation of wound epithelization and healing process.
1 secondary outcome
Surgical wound infection development
Time frame: 1 week, 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Incision and Surgical Site Infection, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the effectiveness of paramedian flap skin incision technique. (time frame: 1 week, 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.