Dermal Wound Closure Using Silkam®
DERMASILK
Assessment of Performance of Silkam® Suture Material for Skin Closure - a Prospective, Single Center, Single Arm, Observational Study in Daily Practice
1 other identifier
observational
161
1 country
1
Brief Summary
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2025
CompletedApril 20, 2026
April 1, 2026
2.9 years
January 26, 2022
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Individual A1 Surgical Site Infection Rate
at suture removal approx. 10 ± 5 days postoperative
Individual A2 Surgical Site Infection Rate
at suture removal approx. 10 ± 5 days postoperative
Adverse Event Rate
at suture removal approx. 10 ± 5 days postoperative
Cosmetic Outcome
at suture removal approx. 10 ± 5 days postoperative
Pain: Visual Analogue Scale (VAS)
at suture removal approx. 10 ± 5 days postoperative
- +2 more secondary outcomes
Other Outcomes (5)
Individual A1 and A2 Surgical Site Infection Rate
at optional follow-up approx. 3 month postoperative
Adverse Event Rate
at optional follow-up approx. 3 month postoperative
Cosmetic Outcome
at optional follow-up approx. 3 month postoperative
- +2 more other outcomes
Eligibility Criteria
Adult and paediatric patients undergoing skin closure
You may qualify if:
- Adult and paediatric patients undergoing skin closure using Silkam® as suture material.
- Written informed consent regarding the data collection for the PMCF study.
You may not qualify if:
- Pregnancy
- Visible dirty wounds
- Patients taking medication that might affect wound healing
- Patients with hypersensitivity or allergy to the suture material
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
- B.Braun Surgical SAcollaborator
Study Sites (1)
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2022
First Posted
February 4, 2022
Study Start
July 21, 2022
Primary Completion
June 25, 2025
Study Completion
June 25, 2025
Last Updated
April 20, 2026
Record last verified: 2026-04