Assessment of DAFILON® Suture Material for Skin Closure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-11

Study Completion Date

2023-06-15

Brief Summary

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In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients. The aim of the study is to collect clinical data on the performance of Dafilon® for skin closure. The results of this study will generate further clinical evidence for the use and the benefit of a non-absorbable surgical suture material produced from polyamide. Furthermore, the proactive collection of clinical data for Dafilon® suture will support the maintenance of the suture material on the market, so that in the future other patients can receive the suture material for skin closure.

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Detailed Description

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Conditions

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Laceration of Skin Injury Skin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent is available
* Patients undergoing skin closure with Dafilon®
* Small linear minimally contaminated incision/laceration in the trunk or extremities

Exclusion:

* Emergency surgery
* Pregnancy
* Facial lacerations or incisions
* Visible dirt in the wounds
* Nonlinear shape
* Patient taking medication that might affect wound healing
* Patient with hypersensitivity or allergy to the suture material

Eligible Sex

ALL

Accepts Healthy Volunteers

No