CompletedNot Applicable

Assessment of DAFILON® Suture Material for Skin Closure

Germany, Spain115 participantsStarted 2021-03-11

Plain-language summary

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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion: * 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

What they're measuring

Combination of Surgical Site Infection (SSI) and Wound Dehiscence

Timeframe: until suture removal 10±5 days postoperatively.

Trial details

NCT IDNCT04617041

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-05-25

View on ClinicalTrials.gov More Laceration of Skin trials