Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Individual A1 and A2 Surgical Site Infection Rate |
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be superficial infections involving the skin only. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material. |
at optional follow-up approx. 3 month postoperative |
|
| Other |
Adverse Event Rate |
frequency of wound dehiscence, hypertrophic scar, keloid scar, inflammation, tissue reaction, seroma, abscess formation, hematoma, granuloma, bleeding, necrosis, skin stripping or irritation. |
at optional follow-up approx. 3 month postoperative |
|
| Other |
Cosmetic Outcome |
Overall patient and observer satisfaction with the scar using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum). |
at optional follow-up approx. 3 month postoperative |
|
| Other |
Pain: Visual Analogue Scale (VAS) |
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". |
at optional follow-up approx. 3 month postoperative |
|
| Other |
Satisfaction of the patient: Visual Analogue Scale (VAS) |
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "very poor" and "100" at the opposite end representing "excellent". |
at optional follow-up approx. 3 month postoperative |
|
| Primary |
Surgical Site Infection Rate |
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be superficial infections involving the skin only (A1). Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material. (A2) |
at suture removal approx. 10 ± 5 days postoperative |
|
| Secondary |
Individual A1 Surgical Site Infection Rate |
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be superficial infections involving the skin only (A1). |
at suture removal approx. 10 ± 5 days postoperative |
|
| Secondary |
Individual A2 Surgical Site Infection Rate |
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be more serious and can involve tissues under the skin, organs, or implanted material. (A2) |
at suture removal approx. 10 ± 5 days postoperative |
|
| Secondary |
Adverse Event Rate |
frequency of wound dehiscence, hypertrophic scar, keloid scar, inflammation, tissue reaction, seroma, abscess formation, hematoma, granuloma, bleeding, necrosis, skin stripping or irritation. |
at suture removal approx. 10 ± 5 days postoperative |
|
| Secondary |
Cosmetic Outcome |
Overall patient and observer satisfaction with the scar using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum). |
at suture removal approx. 10 ± 5 days postoperative |
|
| Secondary |
Pain: Visual Analogue Scale (VAS) |
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". |
at suture removal approx. 10 ± 5 days postoperative |
|
| Secondary |
Satisfaction of the patient: Visual Analogue Scale (VAS) |
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "very poor" and "100" at the opposite end representing "excellent". |
at suture removal approx. 10 ± 5 days postoperative |
|
| Secondary |
Assessment of the handling of the suture material |
Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag, pliability) with 5 evaluation levels (excellent, very good, good, satisfied, poor). |
intraoperative |
|
