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Completed

NCT Number: NCT05225714

Dermal Wound Closure Using Silkam®

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Surgical Site Infection Rate

    Time frame: 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 outcomes

  1. Individual A1 Surgical Site Infection Rate

    Time frame: 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).

  2. Individual A2 Surgical Site Infection Rate

    Time frame: 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)

  3. Adverse Event Rate

    Time frame: 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.

  4. Cosmetic Outcome

    Time frame: 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).

  5. Pain: Visual Analogue Scale (VAS)

    Time frame: 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".

  6. Satisfaction of the patient: Visual Analogue Scale (VAS)

    Time frame: 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".

  7. Assessment of the handling of the suture material

    Time frame: 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).

Other outcomes

  1. Individual A1 and A2 Surgical Site Infection Rate

    Time frame: at optional follow-up approx. 3 month 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. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material.

  2. Adverse Event Rate

    Time frame: at optional follow-up approx. 3 month postoperative

    frequency of wound dehiscence, hypertrophic scar, keloid scar, inflammation, tissue reaction, seroma, abscess formation, hematoma, granuloma, bleeding, necrosis, skin stripping or irritation.

  3. Cosmetic Outcome

    Time frame: at optional follow-up approx. 3 month 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).

  4. Pain: Visual Analogue Scale (VAS)

    Time frame: at optional follow-up approx. 3 month 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".

  5. Satisfaction of the patient: Visual Analogue Scale (VAS)

    Time frame: at optional follow-up approx. 3 month 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".

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Assessment of Performance of Silkam® Suture Material for Skin Closure - a Prospective, Single Center, Single Arm, Observational Study in Daily Practice

Acronym: DERMASILK

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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