Dermal Wound Closure Using Silkam®

Recruiting

• Conditions: Contusions; Incision; Laceration

• Registration Number: NCT05225714
• Lead Sponsor: Aesculap AG

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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-04
• Study Start: 2022-07-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection Rate	at suture removal approx. 10 ± 5 days postoperative	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)

Secondary Outcome Measures

Name	Time	Method
Pain: Visual Analogue Scale (VAS)	at suture removal approx. 10 ± 5 days postoperative	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".
Cosmetic Outcome	at suture removal approx. 10 ± 5 days postoperative	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).
Assessment of the handling of the suture material	intraoperative	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).
Adverse Event Rate	at suture removal approx. 10 ± 5 days postoperative	frequency of wound dehiscence, hypertrophic scar, keloid scar, inflammation, tissue reaction, seroma, abscess formation, hematoma, granuloma, bleeding, necrosis, skin stripping or irritation.
Individual A1 Surgical Site Infection Rate	at suture removal approx. 10 ± 5 days postoperative	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).
Individual A2 Surgical Site Infection Rate	at suture removal approx. 10 ± 5 days postoperative	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)
Satisfaction of the patient: Visual Analogue Scale (VAS)	at suture removal approx. 10 ± 5 days postoperative	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".

Trial Locations

Locations (1)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Spain