Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery

Scar Clinical Trial

— SCARMICS  

Official title:

Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527756
• Other study ID #: f/2022/121
• Status: Completed
• Start date: October 21, 2022
• Est. completion date: May 27, 2023

Study information

• Verified date: March 2024
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Totally endoscopic cardiac surgery (TECS) is considered to have aesthetic advantages over conventional median sternotomy due to the smaller incisions. Most research regarding TECS focuses on clinical outcomes instead of cosmetic consequences. Following surgery, postoperative scarring is unavoidable and may negatively affect the patient's physical and emotional well-being. Therefore, this study aims to investigate the cosmesis after TECS.

Description:

Totally endoscopic cardiac surgery (TECS) is considered to have aesthetic advantages over conventional median sternotomy due to the smaller incisions. Most research regarding TECS focuses on clinical outcomes instead of cosmetic consequences. Following surgery, postoperative scarring is unavoidable and may negatively affect the patient's physical and emotional well-being. One previous study compared median sternotomy cardiac surgery and TECS in terms of the long-term cosmetic appearance of postoperative scars. They concluded that scars were considered more satisfactory, less painful, and itchy in the TECS group in the Chinese population. To our knowledge, this is the only study published regarding cosmetic consequences after TECS. Therefore, this study aims to investigate the cosmesis after TECS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 27, 2023
• Est. primary completion date: May 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years old
• Patients who can give their informed consent
• Patients who speak Dutch or French

Exclusion Criteria:

• Patients that previously underwent cardiac surgery
• Patients that will undergo a combination of cardiac surgeries

Related Conditions & MeSH terms

• Minimally Invasive Cardiac Surgery
• Scar

Intervention

Other:
• Scar Cosmesis Assessment and Rating (SCAR) scale
The SCAR scale consists of two simple questions about symptoms (itch and pain) with yes/no response options that are responded to by the patient and six clinician-related items that are rated by observers through photos of the incisions. This scale includes both objective measurements and patient-reported symptoms
• Numerical rating scale (NRS)
The NRS scale, in which the patients score the cosmetic appearance of the scar from 0 to 10, is questioned.

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day one.	The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.	Postoperative day one
Primary	Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 14.	The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.	Postoperative day 14
Primary	Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 30.	The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.	Postoperative day 30
Secondary	Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day one.	The cosmetic appearance of the scar is scored from 0 to 10, whereas 0 contributes to not satisfied with the scar and 10 with very satisfied with the scar.	Postoperative day one
Secondary	Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 14.	The cosmetic appearance of the scar is scored from 0 to 10, whereas 0 contributes to not satisfied with the scar and 10 with very satisfied with the scar.	Postoperative day 14
Secondary	Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 30.	The cosmetic appearance of the scar is scored from 0 to 10, whereas 0 contributes to not satisfied with the scar and 10 with very satisfied with the scar.	Postoperative day 30