Silastic Sheet Usefulness Following Septoplasty
1 other identifier
interventional
50
1 country
1
Brief Summary
This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique. Methods: A single center randomized controlled trial, including adult above the age of 18. A total of 50 participants who underwent septoplasty were enrolled and randomly assigned into two groups, Silastic group (n=25), and quilting group (n=25). Nasal obstruction severity was assessed by using an Arabic validated version of NOSE score, preoperatively then 3 days, one week and one month postoperatively. Post-operative complications were assessed at outpatient clinic 1 week and 1 month postoperatively. Pain was assessed by a 10-point numerical scales via phone call on the 3rd day postoperative.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2021
CompletedFirst Submitted
Initial submission to the registry
June 4, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedJune 10, 2021
June 1, 2021
6 months
June 4, 2021
June 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in NOSE score 1 month postoperatively
NOSE change = preoperative NOSE - 1 month postoperative NOSE
1 month postoperatively
Secondary Outcomes (4)
Validated NOSE score
NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively
complications
1 month
postoperative pain
at 3 days postoperative
general satisfaction questionnaire
at 1 month postoperative
Study Arms (2)
Silastic group
ACTIVE COMPARATORincluded patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint
Quilting group
ACTIVE COMPARATORincluded patients who underwent septoplasty followed by quilting suture (Septal through and through suture)
Interventions
septoplasty procedures were performed by a single surgeon using the same technique among all patients. The procedures were conducted under general anesthesia according to the standard preoperative care used in our institution.
Eligibility Criteria
You may qualify if:
- Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.
You may not qualify if:
- \. Concomitant procedure other than septoplasty. 2. Previous history of septal or nasal surgery. 3. Presence of nasal polyps, chronic sinusitis or other regional pathology. 4. Bleeding disorders or anticoagulation therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdulaziz Medical City
Riyadh, 14611, Saudi Arabia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical intern
Study Record Dates
First Submitted
June 4, 2021
First Posted
June 10, 2021
Study Start
September 29, 2020
Primary Completion
March 31, 2021
Study Completion
May 4, 2021
Last Updated
June 10, 2021
Record last verified: 2021-06