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

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

Study Overview

• Status: Completed
• Conditions: Laceration; Contusions; Incision

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.

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult and paediatric patients undergoing skin closure

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	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.	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).	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".	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".	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).	intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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".	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".	at optional follow-up approx. 3 month postoperative

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): June 25, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating; Surgical Wound; Lacerations; Contusions
• Other Study ID Numbers: AAG-O-H-1929

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No