Clinical trial NCT05240248: Optilene® Suture Material for Dermal Sutures
Official title: Assessment of Optilene® Suture Material for Skin Closure (Dermal Sutures). A Prospective Single-arm Observational Study in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laceration
Incision
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2022-02-15
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing skin closure using Optilene® suture material.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical Site Infection Rate
timeFrame: at suture removal approximately 10±5 days postoperatively.
Secondary outcomes:
measure: Surgical Site Infection Rate
timeFrame: at discharge from hospital (up to 5 days postoperatively)
measure: Surgical Site Infection Rate
timeFrame: at follow-up examination approximately 30±10 days postoperatively
measure: Wound dehiscence rate
timeFrame: at discharge from hospital (up to 5 days postoperatively)
measure: Wound dehiscence rate
timeFrame: at suture removal approximately 10±5 days postoperatively.
measure: Wound dehiscence rate
timeFrame: at follow-up examination approximately 30±10 days postoperatively
measure: Cumulative rate of Adverse Events during the study period
timeFrame: 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
measure: Development of Cosmetic Outcome
timeFrame: 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
measure: Development of Pain: Visual Analogue Scale (VAS)
timeFrame: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
measure: Development of Satisfaction of the patient: Visual Analogue Scale (VAS)
timeFrame: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
measure: Duration of surgery
timeFrame: intraoperatively
measure: Handling of the suture material
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
Study officials:
References: