Scar Clinical Trial
— SCARMICSOfficial title:
Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery
NCT number | NCT05527756 |
Other study ID # | f/2022/121 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 21, 2022 |
Est. completion date | May 27, 2023 |
Verified date | March 2024 |
Source | Jessa Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Jessa Hospital | Hasselt | Limburg |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital |
Belgium,
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 |
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