Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
The prospective, monocentric, single-arm, observational Post Market Clinical Follow-Up (PMCF) study is done to continue to evaluate the safety and performance of Silkam® suture material for skin closure under clinical routine. Safety and effectiveness parameters commonly used in skin closure are to be used to evaluate the performance of the suture material. The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Silkam® suture material under the daily routine clinical practice when used for skin closure as intended.
Study Type
OBSERVATIONAL
Enrollment
164
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
RECRUITINGSurgical 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)
Time frame: at suture removal approx. 10 ± 5 days postoperative
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).
Time frame: at suture removal approx. 10 ± 5 days postoperative
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)
Time frame: at suture removal approx. 10 ± 5 days postoperative
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.
Time frame: at suture removal approx. 10 ± 5 days postoperative
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).
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Time frame: at suture removal approx. 10 ± 5 days postoperative
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".
Time frame: at suture removal approx. 10 ± 5 days postoperative
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".
Time frame: at suture removal approx. 10 ± 5 days postoperative
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).
Time frame: intraoperative