Comparative Evaluation of clinical outcome between 4-0 Polydioxanone and 4-0 vicryl suture for closure in Primary Cleft Palate Surgery
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Wound Dehiscence, Wound healing, Mucosal Scarring, Suppuration
Study Overview
Brief Summary
â—Vicryl is an absorbable, synthetic suture which is a braided copolymer of glycolic and lactic acid that is surface treated with polyglactin 370 and calcium stearate and has received gamma radiation. This radiation alters the suture material’s molecular structure and enhances its absorption rate in vivo.
â—Polydioxanone (PDS) or poly-p-dioxanone is a slowly absorbable monofilament suture composed of the polyester, poly (p-dioxanone). This is a monofilament with greater strength than monofilament nylon and polypropylene, and with less tissue drag than the multifilament materials.
Aim: To Compare and evaluate wound healing using 4-0 PDS and 6-0 Vicryl in cleft palate surgery.
Null Hypothesis: There is no difference in surgical outcome between the suture materials after primary palatoplasty
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 0.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with primary cleft palate Non syndromic patients.
Exclusion Criteria
- •Syndromic Patients Palatal Fistula Medically compromised patients.
Outcomes
Primary Outcomes
Wound Dehiscence, Wound healing, Mucosal Scarring, Suppuration
Time Frame: follow up 1 week, 1 month, 3 months, 6 months
Secondary Outcomes
- Mucosal Scarring, Suppuration(follow up 1 week, 1 month, 3 months, 6 months)
Investigators
Dr Shrishty Bhardwaj
Saveetha Dental College