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NCT Number: NCT04390620

Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients

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Key information

Conditions

Oral Surgery Dental Implants Tooth Extraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie, Esslingen am Neckar, Germany

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About this study

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients.

The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients undergoing mucosal wound closure using Dafilon as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be included).
  • Written informed consent regarding the data collection for the PMCF.

Exclusion criteria

  • Emergency surgery.
  • Oral surgery procedures requiring bone regeneration.
  • Pregnancy.
  • Patients taking medication that might affect wound healing.
  • Patients with hypersensitivity or allergy to the suture material.

Treatment and study plan

Mucosal Closure

Device

mucosal closure in oral surgery (mucosal sutures)

Primary outcomes

  1. incidence of combined postoperative complications Grade I and Grade II

    Time frame: 10 ± 5 days postoperatively (suture removal)

    combined incidence of postoperative complications Grade I & II on a Five Point scale defined by Askar et al. (Grade I: postoperative dentinal hypersensitivity / Oral candidiasis / Angular cheilitis / Exaggerated swelling defined as postoperative enlargement of tissues that exceeds the normal limits associated with a given surgical procedure / Delayed wound healing defined as an unusual deviation from the normal course of healing / Mild postoperative bleeding defined as the presence of small amount of blood in the oral cavity, usually mixed with saliva; Grade II: Flap dehiscence / Membrane exposure / Localized infection of the surgical site / Graft necrosis)

Secondary outcomes

  1. Incidence of individual postoperative complications

    Time frame: until suture removal 10 ± 5 days postoperative

    incidence of postoperative complications of Grade I - V on a Five Point scale defined by Askar et al. (Grade I & II see Primary Outcome; Grade III: Fever / Skin rash / Neuropraxia/paresthesia / Trimus / Osteomyelitis / Septicemia / Sinusitis / Alveolar osteitis / Chymosis / Excessive and severe bleeding / Prolonged exaggerated swelling; Grade IV: Major complications that required immediate hospitalization such as drug induced anaphylaxis or septicemia; Grade V: Major complications that led to irreversible damage such neurotmesis and axonotmesis)

  2. Pain assessment using the visual analogue scale (VAS 1-100)

    Time frame: at suture removal 10 ± 5 days postoperative

    This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain".

  3. Satisfaction of the patient using the visual analogue scale (VAS 1-100)

    Time frame: at suture removal 10 ± 5 days postoperative

    This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "completely satisfied" and "100" at the opposite end representing "not at all satisfied".

  4. Wound healing assessment using the visual analogue scale (VAS 1-100)

    Time frame: at suture removal 10 ± 5 days postoperative

    This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good wound healing" and "100" at the opposite end representing "very bad wound healing".

  5. knot security

    Time frame: intraoperative

    Evaluation of Knot security with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,

  6. tensile strength

    Time frame: intraoperative

    Evaluation of tensile strength with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,

  7. knot run down

    Time frame: intraoperative

    Evaluation of knot run down with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,

  8. tissue drag

    Time frame: intraoperative

    Evaluation of tissue drag with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,

  9. pliability

    Time frame: intraoperative

    Evaluation of pliability with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,

Other outcomes

  1. Bacterial contamination of the thread

    Time frame: at suture removal 10 ± 5 days postoperative

    optional

  2. Pain assessment using the visual analogue scale (VAS 1-100)

    Time frame: at follow-up up to five months postoperative

    Optional: This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain".

  3. Satisfaction of the patient using the visual analogue scale (VAS 1-100)

    Time frame: at follow-up up to five months postoperative

    Optional: This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "completely satisfied" and "100" at the opposite end representing "not at all satisfied".

  4. Wound healing assessment using the visual analogue scale (VAS 1-100)

    Time frame: at follow-up up to five months postoperative

    Optional: This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good wound healing" and "100" at the opposite end representing "very bad wound healing".

  5. Cosmetic outcome assessed by the physician using the visual analogue scale (VAS 1-100)

    Time frame: at follow-up up to five months postoperative

    Optional: This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good cosmetic outcome" and "100" at the opposite end representing "very bad cosmetic outcome".

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice

Acronym: MUCODA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 15, 2020
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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