Dermal Wound Closure Using Silkam®

NCT ID: NCT05225714

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-21

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Contusions Incision Laceration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.Braun Surgical SA

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Joan Lluis Pérez Moreno

Role: CONTACT

+34 935 86 62 00

José Manuel M Molina Villar, Dr.

Role: CONTACT

+34 935 86 62 ext. 00

Facility Contacts

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José Hernández Hermoso, Dr.

Role: primary

Other Identifiers

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AAG-O-H-1929

Identifier Type: -

Identifier Source: org_study_id

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