OBJECTIVES/HYPOTHESIS: Absorbable packing materials are commonly used after endoscopic sinus surgery (ESS). Cutanplast is a novel gelatin sponge with a powerful hemostatic effect that is rapidly absorbed. The purpose of this study was to investigate the efficacy of Cutanplast in patients following ESS. STUDY DESIGN: A multicenter, prospective, randomized, double-blind, paired, controlled trial. METHODS:One hundred adult patients with chronic sinusitis requiring the same extent of ESS were included. Patients were excluded if they were undergoing septoplasty, turbinate surgery, revision surgery, and taking anticoagulants. Following surgery, one nasal cavity was packed with Cutanplast and the other one with Merocel. Hemostatic properties, patient discomfort while the packing was in situ, patient pain on removal, degree of bleeding on removal, time required to control bleeding after removal, the cost of the pack, and postoperative wound healing were evaluated. RESULTS: Both packs were effective at preventing postoperative hemorrhage. However, Cutanplast was significantly more comfortable while in situ (mean difference, 0.90; 95% confidence interval [CI], 0.75-1.25) and less painful on removal of the pack (mean difference, 1.36; 95% CI, 0.85-1.71). The Merocel pack was associated with significantly more bleeding on removal (mean difference, 1.23; 95% CI, 0.61-2.29), therefore much time was needed to control hemorrhage (mean difference, 1.05; 95% CI, 0.31-1.45). There was no significant difference in the cost of the pack used and outcome measure of wound healing. CONCLUSIONS: Cutanplast nasal pack results in significantly less pain and less bleeding compared to Merocel pack.
RCT Entities:
OBJECTIVES/HYPOTHESIS: Absorbable packing materials are commonly used after endoscopic sinus surgery (ESS). Cutanplast is a novel gelatin sponge with a powerful hemostatic effect that is rapidly absorbed. The purpose of this study was to investigate the efficacy of Cutanplast in patients following ESS. STUDY DESIGN: A multicenter, prospective, randomized, double-blind, paired, controlled trial. METHODS: One hundred adult patients with chronic sinusitis requiring the same extent of ESS were included. Patients were excluded if they were undergoing septoplasty, turbinate surgery, revision surgery, and taking anticoagulants. Following surgery, one nasal cavity was packed with Cutanplast and the other one with Merocel. Hemostatic properties, patient discomfort while the packing was in situ, patientpain on removal, degree of bleeding on removal, time required to control bleeding after removal, the cost of the pack, and postoperative wound healing were evaluated. RESULTS: Both packs were effective at preventing postoperative hemorrhage. However, Cutanplast was significantly more comfortable while in situ (mean difference, 0.90; 95% confidence interval [CI], 0.75-1.25) and less painful on removal of the pack (mean difference, 1.36; 95% CI, 0.85-1.71). The Merocel pack was associated with significantly more bleeding on removal (mean difference, 1.23; 95% CI, 0.61-2.29), therefore much time was needed to control hemorrhage (mean difference, 1.05; 95% CI, 0.31-1.45). There was no significant difference in the cost of the pack used and outcome measure of wound healing. CONCLUSIONS: Cutanplast nasal pack results in significantly less pain and less bleeding compared to Merocel pack.