Clinical trial NCT05225714: Dermal Wound Closure Using Silkam®
Official title: Assessment of Performance of Silkam® Suture Material for Skin Closure - a Prospective, Single Center, Single Arm, Observational Study in Daily Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Contusions
Incision
Laceration
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2022-02-04
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and paediatric patients undergoing skin closure

Brief summary: Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult and paediatric patients undergoing skin closure using Silkam® as suture material.
* Written informed consent regarding the data collection for the PMCF study.

Exclusion Criteria:

* Pregnancy
* Visible dirty wounds
* Patients taking medication that might affect wound healing
* Patients with hypersensitivity or allergy to the suture material

Primary outcomes:
measure: Surgical Site Infection Rate
timeFrame: at suture removal approx. 10 ± 5 days postoperative
Secondary outcomes:
measure: Individual A1 Surgical Site Infection Rate
timeFrame: at suture removal approx. 10 ± 5 days postoperative
measure: Individual A2 Surgical Site Infection Rate
timeFrame: at suture removal approx. 10 ± 5 days postoperative
measure: Adverse Event Rate
timeFrame: at suture removal approx. 10 ± 5 days postoperative
measure: Cosmetic Outcome
timeFrame: at suture removal approx. 10 ± 5 days postoperative
measure: Pain: Visual Analogue Scale (VAS)
timeFrame: at suture removal approx. 10 ± 5 days postoperative
measure: Satisfaction of the patient: Visual Analogue Scale (VAS)
timeFrame: at suture removal approx. 10 ± 5 days postoperative
measure: Assessment of the handling of the suture material
timeFrame: intraoperative
Other outcomes:
measure: Individual A1 and A2 Surgical Site Infection Rate
timeFrame: at optional follow-up approx. 3 month postoperative
measure: Adverse Event Rate
timeFrame: at optional follow-up approx. 3 month postoperative
measure: Cosmetic Outcome
timeFrame: at optional follow-up approx. 3 month postoperative
measure: Pain: Visual Analogue Scale (VAS)
timeFrame: at optional follow-up approx. 3 month postoperative
measure: Satisfaction of the patient: Visual Analogue Scale (VAS)
timeFrame: at optional follow-up approx. 3 month postoperative
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
Study officials:
References: