An observational study in Contusions, Incision and Laceration, sponsored by Aesculap AG. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Aesculap AG (part of B. Braun) · Observational
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.
43 studies on the registry are indexed under Contusions; 8 are open to participants now.
This study's enrollment of 161 is above the median of 75 across 10 observational studies indexed under Contusions.
Browse Contusions studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult and paediatric patients undergoing skin closure
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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).
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
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.
Time frame: at optional follow-up approx. 3 month 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 optional follow-up approx. 3 month 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).
Time frame: at optional follow-up approx. 3 month 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 optional follow-up approx. 3 month 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 optional follow-up approx. 3 month postoperative
Ran from Jul 2022 to primary completion in Jun 2025, 35 months.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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