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A study to compare the appearance of scar after using either tissue glue or stitches for closing facial surgery wound

Not Applicable
Completed
Conditions
Medical and Surgical,
Registration Number
CTRI/2019/11/022020
Lead Sponsor
Department of Oral Maxillofacial Surgery
Brief Summary

This study is a prospective, randomized, single blinded, unicentre study to compare the esthetic outcomes of octyl-2-cyanoacrylate and ethilon sutures carried out in a total of 20 patients. The primary outcome evaluates and compares the esthetic resuts of octyl-2-cyanoacrylate and ethilon sutures using Manchester Scar Scale at the end of 1st month and 3rd month post-operatively while secondary outcome observes the tissue response and incidence of complications using Wound Evaluation Scale & ASEPSIS Score at Day 7, Day 15 and end of 1st month post-operatively as well as compares the time taken in skin closure.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Patients between age group 15-50 years.
  • Patients both males and females will be included.
  • Clean elective extra-oral surgical incisions.
  • Patients who would require retromandibular or submandibular surgical incisions.
  • Extra-oral surgical incision length 2-8cm.
  • Incision with good approximation of edges where closure would not be under tension.
Exclusion Criteria
  • Patients with systemic conditions impairing wound healing (uncontrolled diabetes mellitus, vascular problems, coagulation disorders, peripheral vascular disorders).
  • Patients on immunomodulators (steroids, cyclosporine).
  • Patients with known tendency of hypertrophic scar or keloid formation.
  • Extra-oral surgical wounds in the region of malignancy.
  • Extra-oral surgical wounds in the region of mucocutaneous junction, periocular region.
  • Extra-oral surgical wounds in the region where there is visual evidence of active infection, rash or skin lesions.
  • Extra-oral surgical wounds in the region covered by natural hair.
  • Patients with known history of hypersensitivity to formaldehyde or cyanoacrylates.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the esthetic results achieved using octyl-2-cyanoacrylate skin adhesive and ethilon suture in patients requiring skin incisions in maxillofacial surgeryEnd of 1st and 3rd post-operative month
Secondary Outcome Measures
NameTimeMethod
Observe tissue response and incidence of complications involved with the use of octyl-2-cyanoacrylate skin adhesive and ethilon suture in patients requiring skin incisions in maxillofacial surgery7th, 15th day and 1st month post-operatively
Compare the time taken for skin closure achieved using octyl-2-cyanoacrylate skin adhesive and ethilon suture in patients requiring skin incisions in maxillofacial surgeryat the time of closure

Trial Locations

Locations (1)

MGM Dental College and Hospital

🇮🇳

Raigarh, MAHARASHTRA, India

MGM Dental College and Hospital
🇮🇳Raigarh, MAHARASHTRA, India
Dr Ruchita Balkawade
Principal investigator
9082265483
ruchitabalkawade11@gmail.com

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