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Completed

NCT Number: NCT05240248

Optilene® Suture Material for Dermal Sutures

In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.

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Key information

Conditions

Laceration Incision Lacerations Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

About this study

The study is designed as a prospective, unicentric and single-arm observational study to evaluate Optilene® suture material for skin closure.

The product under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). After operation the investigator will examine the patients at discharge, at 10±5 days after surgery (removal of the suture) and 30±10 days postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients undergoing skin closure using Optilene® suture material.
  • Small (0.5 cm - 10 cm) linear minimally contaminated incision/laceration in the trunk, neck or extremities (in the event that more than one incision is performed in the same patient, only one incision will be included).
  • Written informed consent.

Exclusion criteria

  • Emergency surgery.
  • Transplant surgery.
  • Pregnancy.
  • Facial laceration or incision.
  • Visible dirt in the wound.
  • Non-linear shape.
  • Patient with limb ischemia.
  • Patient taking medication that might affect wound healing (i.e. cytotoxic antineoplastic and immunosuppressive agents, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants).
  • Patient with hypersensitivity or allergy to the suture material.

Treatment and study plan

Primary outcomes

  1. Surgical Site Infection Rate

    Time frame: at suture removal approximately 10±5 days postoperatively.

    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.

Secondary outcomes

  1. Surgical Site Infection Rate

    Time frame: at discharge from hospital (up to 5 days postoperatively)

    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. Surgical Site Infection Rate

    Time frame: at follow-up examination approximately 30±10 days postoperatively

    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.

  3. Wound dehiscence rate

    Time frame: at discharge from hospital (up to 5 days postoperatively)

    Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.

  4. Wound dehiscence rate

    Time frame: at suture removal approximately 10±5 days postoperatively.

    Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.

  5. Wound dehiscence rate

    Time frame: at follow-up examination approximately 30±10 days postoperatively

    Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.

  6. Cumulative rate of Adverse Events during the study period

    Time frame: at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively

    frequency of Tissue reaction, Inflammation, Seroma, Abscess formation, Hematoma, Granuloma, Bleeding, Necrosis and Irritation

  7. Development of Cosmetic Outcome

    Time frame: at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively

    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).

  8. Development of Pain: Visual Analogue Scale (VAS)

    Time frame: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively

    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".

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

    Time frame: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively

    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".

  10. Duration of surgery

    Time frame: intraoperatively

    time from cut to closure in minutes.

  11. Handling of the suture material

    Time frame: intraoperatively

    The handling of the suture material is assessed using a questionnaire assessing the Knot security (The quality of a suture that allows it to be tied securely with a minimum number of throws per knot), the Knot pull tensile strength (strength of the thread while knotting), the Knot run down (Ease with which a knot can be slid down), the Tissue drag (Passage through the tissue), the Pliability (The quality of being easily to bent, flexibility) and the Overall opinion of the surgeon each with the 5 evaluation levels of 'excellent', 'very good', 'good', 'satisfied' and 'poor':.

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Assessment of Optilene® Suture Material for Skin Closure (Dermal Sutures). A Prospective Single-arm Observational Study in Daily Practice

Acronym: OPTIDERMAL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Feb 21, 2024

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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