Optilene® Suture Material for Dermal Sutures

Laceration Clinical Trial

— OPTIDERMAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240248
• Other study ID #: AAG-O-H-1928
• Status: Completed
• Start date: June 22, 2022
• Est. completion date: July 23, 2023

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Incision
• Laceration
• Lacerations

Locations

Country	Name	City	State
Spain	Hospital Universitario Doctor Peset	Valencia

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
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. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material.	at suture removal approximately 10±5 days postoperatively.
Secondary	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 discharge from hospital (up to 5 days postoperatively)
Secondary	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 follow-up examination approximately 30±10 days postoperatively
Secondary	Wound dehiscence rate	Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.	at discharge from hospital (up to 5 days postoperatively)
Secondary	Wound dehiscence rate	Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.	at suture removal approximately 10±5 days postoperatively.
Secondary	Wound dehiscence rate	Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.	at follow-up examination approximately 30±10 days postoperatively
Secondary	Cumulative rate of Adverse Events during the study period	frequency of Tissue reaction, Inflammation, Seroma, Abscess formation, Hematoma, Granuloma, Bleeding, Necrosis and Irritation	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
Secondary	Development of 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 discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Secondary	Development of 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 (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Secondary	Development of 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 (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Secondary	Duration of surgery	time from cut to closure in minutes.	intraoperatively
Secondary	Handling of the suture material	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':.	intraoperatively