Clin Exp Otorhinolaryngol.  2017 Sep;10(3):248-253. 10.21053/ceo.2016.01081.

Efficacy and Safety of Guardcel Nasal Packing After Endoscopic Sinus Surgery: A Prospective, Single-Blind, Randomized Controlled Study

• Kang B
• Kim JR
• Shin JM
• Park IH
• Lee HM

• KMID: 2395739
• DOI: http://doi.org/10.21053/ceo.2016.01081

Abstract

OBJECTIVES
Nasal packing after endoscopic sinus surgery is frequently used to control postoperative bleeding, enhance the wound healing process, and prevent lateralization of the middle turbinate, which causes insufficient ventilation. Many biodegradable materials have been developed to reduce pain and mucosal damage during packing removal. The purpose of this study was to compare the efficacy of Guardcel (Genewel Co.) middle meatal packing with a traditional nonabsorbable middle meatal packing, Merocel (Medtronic Xomed), on wound healing and patient satisfaction.
METHODS
In this prospective, single-blind, randomized controlled study, we enrolled 32 consecutive patients (64 nostrils) undergoing bilateral endoscopic sinus surgery at Korea University Guro Hospital from February 2015 to August 2015. Guardcel and Merocel were inserted postoperatively into a randomly assigned side. Objective findings about bleeding, hemostasis, adhesion, and infection were evaluated with nasal endoscopy. Patients' symptoms including pain and nasal obstruction were evaluated with a visual analog scale. Each evaluation was done at 2-3 days, 1 week, 2 weeks, and 4 weeks after surgery.
RESULTS
At 2-3 days after endoscopic sinus surgery, the Guardcel side had a significantly less hemostasis time than the Merocel side (P=0.001). During this period, the pain during packing removal was significantly lower on the Guardcel-inserted side than the Merocel-inserted side (P=0.002). At two weeks after surgery, the adhesion score on the Guardcel side was significantly lower than that of the Merocel side (P=0.011). Other parameters during the study follow-up periods were not statistically significant. There were no severe adverse reactions.
CONCLUSION
Guardcel, a newly developed packing material, appeared to shorten the hemostasis time and reduce pain sensation at 2-3 days after surgery; it also prevented adhesion formation 2 weeks after surgery when compared with the control. Guardcel can be an effective and safe candidate to replace conventional packing materials after endoscopic sinus surgery.

Keyword

Nasal Packing; Absorbable Packing; Hemostasis; Adhesion; Endoscopic Sinus Surgery

MeSH Terms

Endoscopy
Follow-Up Studies
Hemorrhage
Hemostasis
Humans
Korea
Nasal Obstruction
Patient Satisfaction
Prospective Studies*
Sensation
Turbinates
Ventilation
Visual Analog Scale
Wound Healing

Figure

• 

  Fig. 1. (A) Gross shape of Guardcel (Genewel Co.) and (B) endoscopic findings in the left middle meatus after Guardcel packing at the conclusion of surgery.

• 

  Fig. 2. Follow-up endoscopic findings. Images of left middle meatus which side Guardcel (Genewel Co.) was inserted to (A) one week after surgery. Degraded packing material was remained. (B) Four weeks after surgery. And images of right middle meatus which side Merocel (Medtronic Xomed) was inserted to, (C) one week after surgery. Lots of crusts were noted. Packing material had been removed at 2–3 day after surgery. (D) Four-weeks after surgery.

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  Fig. 3. Consolidated Standards of Reporting Trials (CONSORT) diagram of the randomized controlled trial.

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  Fig. 4. Comparison of the hemostasis time between Guardcel (Genewel Co.) and Merocel (Medtronic Xomed) groups on each postoperative day (POD). At 2 or 3 days after surgery, the Guardcel side had significantly shorter hemostasis times (*P<0.05).

• 

  Fig. 5. Comparison of the grade of adhesion between Guardcel (Genewel Co.) and Merocel (Medtronic Xomed) groups on each postoperative day (POD). At the 2nd week visit, the Guardcel side had significantly less adhesion than the Merocel side (*P<0.05). There was no statistically significant difference in adhesion at other times between both groups.

• 

  Fig. 6. Subjective pain scores before and during removal of packing 2-3 days after surgery. The side with Guardcel (Genewel Co.) packing had significantly lower pain scores during packing removal than the side with Merocel (Medtronic Xomed) packing (*P<0.05). There was no statistically significant difference in the pain scores before packing removal between both groups. VAS, visual analog scale.

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  Fig. 7. Changes in nasal obstruction symptoms after endoscopic sinus surgery. There was no statistically significant difference in nasal obstruction symptoms between both groups. VAS, visual analog scale; POD, postoperative days.

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