CompletedNot Applicable

Performance of Safety of SILKAM® Suture Material in Oral Surgery

Spain105 participantsStarted 2022-09-21

Plain-language summary

Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Patients undergoing mucosal wound closure using SILKAM® 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 considered). Exclusion Criteria: * Patients taking medication that might affect wound healing * Patients having a condition that might affect wound healing. * Patients with hypersensitivity or allergy to the suture material. * Participation in another (Randomized) Clinical Trial / Clinical Study. * Non-compliance of patient (i.e. dementia).

What they're measuring

Surgical Wound Dehiscence rate

Timeframe: until day of suture removal (approximately 1 week after surgery)

Complication rate

Timeframe: until day of suture removal (approximately 1 week after surgery)

Trial details

NCT IDNCT05296902

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-21

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