OPTIDERMAL: Optilene® Suture Material for Dermal Sutures
Study Details
Study Description
Brief Summary
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Surgical Site Infection Rate [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 Outcome Measures
- Surgical Site Infection Rate [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.
- Surgical Site Infection Rate [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.
- Wound dehiscence rate [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.
- Wound dehiscence rate [at suture removal approximately 10±5 days postoperatively.]
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
- Wound dehiscence rate [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.
- Cumulative rate of Adverse Events during the study period [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
- Development of Cosmetic Outcome [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).
- Development of Pain: Visual Analogue Scale (VAS) [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".
- Development of Satisfaction of the patient: Visual Analogue Scale (VAS) [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".
- Duration of surgery [intraoperatively]
time from cut to closure in minutes.
- Handling of the suture material [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':.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients undergoing skin closure using Optilene® suture material.
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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).
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Written informed consent.
Exclusion Criteria:
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Emergency surgery.
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Transplant surgery.
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Pregnancy.
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Facial laceration or incision.
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Visible dirt in the wound.
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Non-linear shape.
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Patient with limb ischemia.
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Patient taking medication that might affect wound healing (i.e. cytotoxic antineoplastic and immunosuppressive agents, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants).
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Patient with hypersensitivity or allergy to the suture material.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | Hospital Universitario Doctor Peset | Valencia | Spain | 46017 |
Sponsors and Collaborators
- Aesculap AG
- B.Braun Surgical SA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAG-O-H-1928