Clinical trial NCT04617041: Assessment of DAFILON® Suture Material for Skin Closure
Official title: Assessment of DAFILON® Suture Material for Skin Closure: A Prospective, Multicentric, International, Single-arm, Observational Study in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laceration of Skin
Injury Skin
Keywords: Non-absorbable suture
Skin closure
Surgical site infection
Wound dehiscence
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 115
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients and children

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Combination of Surgical Site Infection (SSI) and Wound Dehiscence
timeFrame: until suture removal 10±5 days postoperatively.
Secondary outcomes:
measure: Individual rate of surgical site infection (SSI) at discharge
timeFrame: until day of discharge (approximately 1-2 days postoperatively)
measure: Individual rate of surgical site infection (SSI) at postoperative Examination
timeFrame: 10±5 days postoperatively
measure: Individual dehiscence rate at discharge
timeFrame: until day of discharge (approximately 1-2 days postoperatively)
measure: Individual dehiscence rate at postoperative Examination
timeFrame: 10±5 days postoperatively
measure: Adverse events
timeFrame: until 10±5 days postoperatively
measure: Progress of Wound healing
timeFrame: until day of discharge (approximately 1-2 days postoperatively), 10±5 days post operatively and at follow-up visit
measure: Progress of Cosmetic result
timeFrame: at 10±5 days (suture removal) and at optional follow-up visit
measure: Rate of hypertrophic scar
timeFrame: 10±5 days postoperatively (suture removal)
measure: Rate of keloid scar
timeFrame: 10±5 days postoperatively (suture removal)
measure: Progress of Pain: Visual Analogue Scale (VAS)
timeFrame: until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively
measure: Progress of Satisfaction: Visual Analogue Scale (VAS)
timeFrame: until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively
measure: Assessment of the handling of the suture material
timeFrame: intra-operatively
measure: Length of hospital stay
timeFrame: until day of discharge (approximately 1-2 days postoperatively)
Other outcomes:
Locations:
city: Tuttlingen
country: Germany
facility: Klinikum Landkreis Tuttlingen, Dept. General Surgery
state: Baden-Württemberg
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
Study officials:
affiliation: Hospital Vall D'Hebrón, Barcelona
name: Manuel Guillermo López Paredes, Dr.
role: PRINCIPAL_INVESTIGATOR
References: