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Completed

NCT Number: NCT04921462

Silastic Sheet Usefulness Following Septoplasty

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.

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Key information

Conditions

Septoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz Medical City

Riyadh, 14611, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.

Exclusion criteria

  • 1. 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.

Treatment and study plan

Septoplasty surgery

Procedure

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.

Primary outcomes

  1. Change in NOSE score 1 month postoperatively

    Time frame: 1 month postoperatively

    NOSE change = preoperative NOSE - 1 month postoperative NOSE

Secondary outcomes

  1. Validated NOSE score

    Time frame: NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively

  2. complications

    Time frame: 1 month

    Bleeding, Bad smell, Synechia, Crustation and Perforation

  3. postoperative pain

    Time frame: at 3 days postoperative

    using numerical Pain scale (0 to 10)

  4. general satisfaction questionnaire

    Time frame: at 1 month postoperative

Sponsors and collaborators

Lead sponsor

King Abdulaziz Medical City

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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