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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05225714
Other study ID # AAG-O-H-1929
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 21, 2022
Est. completion date December 2024

Study information

Verified date October 2023
Source Aesculap AG
Contact Aina L Fernández Rodríguez
Phone +34 935 86 62 00
Email info@bbraun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital Universitari Germans Trias i Pujol Badalona

Sponsors (2)

Lead Sponsor Collaborator
Aesculap AG B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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
Other 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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