This trial is active, not recruiting.

Condition nasal obstruction
Treatment septal stapler
Sponsor University of Alberta
Start date February 2012
End date September 2012
Trial size 16 participants
Trial identifier NCT01541839, 00028960


The primary objective of this study is to determine if there is a time savings in the operating room by using a septal stapler instead of suture in closure of primary septoplasty.

The secondary objectives are to determine the subjective outcome of patients undergoing closure with the septal stapler instead of suture via questionnaire, and to determine if there is a difference in postoperative complications between groups.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
This group will have closure of their nasal septal flaps via septal stapler.
septal stapler ENTact Septal Stapler (ENTrigue surgical 601-00100)
This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.
(No Intervention)
This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.

Primary Outcomes

Operative Time
time frame: 1 day

Secondary Outcomes

Subjective function
time frame: 3 weeks, 2 months
Post-operative complications
time frame: 3 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - primary septoplasty - age>18 - septal deviation - ability to read and communicate in English - absence of allergic rhinitis - non-smoker Exclusion Criteria: - revision septoplasty - age <18 - concurrent sinusitis or endoscopic sinus surgery - existing nasal septal perforation - smoker - diabetes mellitus - allergy to polylactide-co-glycolide (PLG) - non-English speaker

Additional Information

Official title Randomized, Controlled Trial Comparing an Endoscopic Septal Stapler to Suture Closure in Primary Septoplasty
Principal investigator Erin D Wright, MDCM, FRCSC
Description Nasal Septoplasty is the third most common surgical procedure performed by otolaryngologists. The surgery is done to relieve nasal obstruction, which is often caused by a bend in the tissues in the middle of the nose. The current technique for completing a septoplasty involves elevating subperichondrial flaps bilaterally and resecting the deviated portion of cartilage and/or bone. The technique to prevent a septal hematoma by removing the potential dead space after cartilage resection has evolved over time. Traditionally, the nose was packed with petroleum gauze, but using sutures to coapt the mucosa back together has become the preferred method of choice. Placing sutures to reapproximate the mucosa is very effective, but can be challenging, particularly in a narrow nose. The amount of time required varies from 4 to 20 minutes for this part of the surgery, and is potentially associated with its own set of complications. The needle or suture can break, and the lateral nasal wall can be traumatized, leading to formation of scar bands to the septum. Recently, a septal stapler has been developed that uses bioabsorbable staples. The staples are made of polylactide-co-glycolide (PLG), the same copolymer found in Vicryl sutures. It can provide a more uniform closure, is able to reach the posterior septum and could lead to a significant time savings in the operating room. The stapler has been demonstrated to be safe and effective, and required less than a minute to apply in most studied cases. The amount of time saved in the operating room has not yet been studied.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by University of Alberta.