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

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ClinicalTrials.gov Identifier: NCT04390620
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
B.Braun Surgical SA
Information provided by (Responsible Party):
Aesculap AG

Brief Summary:
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

Condition or disease Intervention/treatment
Oral Surgery Tooth Extraction Dental Implants Device: Mucosal Closure

Detailed Description:

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).

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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : June 2022

Group/Cohort Intervention/treatment
MUCODA
DAFILON - sterile, monofilament, non-absorbable surgical suture material produced from Polyamide
Device: Mucosal Closure
mucosal closure in oral surgery (mucosal sutures)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390620


Contacts
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Contact: Petra Baumann, Dr. +49-7461-95-1646 petra.baumann@aesculap.de
Contact: Ricard Rosique Jové, Dr. +34-935-902283 ricard.rosique@bbraun.com

Locations
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Germany
Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie
Esslingen am Neckar, Germany, 73728
Sponsors and Collaborators
Aesculap AG
B.Braun Surgical SA
Investigators
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Principal Investigator: Nils Weyer, Dr. med. Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie Ästhetische und Plastische Chirurgie
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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT04390620    
Other Study ID Numbers: AAG-O-H-1912
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aesculap AG:
oral surgery
mucosal closure
complication rate