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Laceration of SkinSKINDANCT04617041

Assessment of DAFILON® Suture Material for Skin Closure

An observational study of Laceration of Skin and Injury Skin, run by Aesculap AG at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Laceration of Skin, Injury Skin
How many people
115 participants
Where
2 sitesin 2 countries
Study dates
11 Mar 2021to 15 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: adult patients and children

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Klinikum Landkreis Tuttlingen, Dept. General Surgery

    Tuttlingen, Baden-Wurttemberg, 78532

Other trials in Germany

Spain1 site

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

About this study

Official title: Assessment of DAFILON® Suture Material for Skin Closure: A Prospective, Multicentric, International, Single-arm, Observational Study in Daily Practice

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.

Keywords
Non-absorbable suture, Skin closure, Surgical site infection, Wound dehiscence
Medical subject headings
Surgical Wound Infection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combination of Surgical Site Infection (SSI) and Wound Dehiscence

    The hypotheses of the current study is that the combined endpoint which consists of the sum of the wound dehiscence and SSI rate will not be inferior to the rate of 13% published by Sajid M. S. et al., 2014 [Systematic review of absorbable vs non-absorbable sutures used for the closure of surgical incisions. World J Gastrointest Surg 2014 27;6(12): 241-247]

    Measured: until suture removal 10±5 days postoperatively.

Secondary outcomes (13)

  1. Individual rate of surgical site infection (SSI) at discharge

    Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).

    Measured: until day of discharge (approximately 1-2 days postoperatively)

  2. Individual rate of surgical site infection (SSI) at postoperative Examination

    Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).

    Measured: 10±5 days postoperatively

  3. Individual dehiscence rate at discharge

    Incidence of wound dehiscence (skin) in postoperative course

    Measured: until day of discharge (approximately 1-2 days postoperatively)

  4. Individual dehiscence rate at postoperative Examination

    Incidence of wound dehiscence (skin) in postoperative course

    Measured: 10±5 days postoperatively

  5. Adverse events

    Rates of postoperative complications such as tissue reaction or inflammation, seroma, abscess formation, hematoma, granuloma, bleeding, suture removal or re-suturing in postoperative course

    Measured: until 10±5 days postoperatively

  6. Progress of Wound healing

    This parameter will be noted using the Visual Analogue Scale (VAS) which states "0" at one end representing "worst wound healing" and "10" at the opposite end representing "excellent wound healing". The values are compared over postoperative period.

    Measured: until day of discharge (approximately 1-2 days postoperatively), 10±5 days post operatively and at follow-up visit

  7. Progress of Cosmetic result

    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). The values are compared over postoperative period.

    Measured: at 10±5 days (suture removal) and at optional follow-up visit

  8. Rate of hypertrophic scar

    A hypertrophic scar is a cutaneous condition characterized by deposits of excessive amounts of collagen which gives rise to a raised scar, but not to the degree observed with keloids. [wikipedia]

    Measured: 10±5 days postoperatively (suture removal)

  9. Rate of keloid scar

    Keloidal scar is the formation of a type of scar which, depending on its maturity, is composed mainly of either type III (early) or type I (late) collagen. It is a result of an overgrowth of granulation tissue (collagen type 3) at the site of a healed skin injury which is then slowly replaced by collagen type 1. Keloids should not be confused with hypertrophic scars, which are raised scars that do not grow beyond the boundaries of the original wound. [wikipedia]

    Measured: 10±5 days postoperatively (suture removal)

  10. Progress 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". The values are compared over postoperative period.

    Measured: until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively

  11. Progress of Satisfaction: 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". The values are compared over postoperative period.

    Measured: until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively

  12. Assessment of the handling of the suture material

    Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag, stiffness, etc.) with 5 evaluation levels (excellent, very good, good, satisfied, poor)

    Measured: intra-operatively

  13. Length of hospital stay

    Number of days between date of surgery and date of discharge

    Measured: until day of discharge (approximately 1-2 days postoperatively)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start11 Mar 2021
  3. Primary completion25 May 2023
  4. Study completion15 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617041
Sponsor's protocol ID
AAG-O-H-1909
Acronym
SKINDA
Status last verified
Jul 2023
First submitted
20 Oct 2020
Last updated
10 Jul 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Laceration of Skin and Injury Skin, run by Aesculap AG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combination of Surgical Site Infection (SSI) and Wound Dehiscence (time frame: until suture removal 10±5 days postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04617041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.

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