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Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in children undergoing
Ronald A Mathiasen1, Raul M Cruz
1Department of Head & Neck Surgery, Kaiser Permanente Medical Center, Oakland, CA 94611, USA. DoctorRam@aol.com
Insights
FloSeal matrix hemostatic sealant significantly reduced bleeding and recovery time in children undergoing adenoidectomy compared to traditional cautery. This safe and effective sealant offers a cost-effective alternative for otolaryngologists.
Area of Science:
- Otorhinolaryngology
- Surgical Hemostasis
- Pediatric Surgery
Background:
- Adenoidectomy is a common pediatric surgical procedure.
- Controlling bleeding during adenoidectomy is crucial for patient safety and recovery.
- Traditional hemostatic methods like cautery can be time-consuming and may lead to complications.
Purpose of the Study:
- To compare the efficacy and safety of FloSeal matrix hemostatic sealant versus traditional suction cautery for hemostasis in pediatric adenoidectomy.
- To evaluate objective and subjective measures of bleeding, operative time, and patient recovery.
Main Methods:
- A prospective, randomized, controlled trial involving 70 children undergoing adenoidectomy.
- Patients were randomized to receive either FloSeal sealant or cautery for hemostasis.
- Data collected included time to hemostasis, blood loss, surgeon-reported bleeding and ease of operation, and patient diet and narcotic use postoperatively.
Main Results:
- FloSeal significantly reduced time to hemostasis (0.6 vs 9.5 minutes) and blood loss (2.5 vs 29.4 mL) compared to cautery (P < 0.001).
- Surgeons reported significantly less bleeding and easier operations with FloSeal (P < 0.001).
- Patients treated with FloSeal returned to a regular diet earlier and required less narcotic use postoperatively (P < 0.05).
Conclusions:
- FloSeal matrix hemostatic sealant is a safe, effective, and easy-to-use option for achieving hemostasis in pediatric adenoidectomy.
- It offers significant advantages over traditional cautery, including reduced bleeding, faster recovery, and cost-effectiveness.
- FloSeal can be considered a valuable first-line hemostatic agent for otolaryngologists.
Problem Addressed:
Floseal is a novel matrix hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin. It is applied as a high-viscosity gel for hemostasis and has been clinically proven to control bleeding. This study is a prospective, randomized, controlled clinical trial of Floseal sealant compared to traditional suction cautery hemostasis in children undergoing adenoidectomy.
Methods And Measures:
Seventy patients (mean age 7.0 yrs, 45.7% male) with obstructive sleep apnea underwent traditional cold steel adenoidectomy with an adenoid curette and were then randomized to receive the hemostatic sealant (Floseal) or cautery to obtain hemostasis. Patients were crossed over to the other hemostatic technique if hemostasis was not achieved after more than 100 mL of blood loss or 15 minutes elapsed time. Objective data collected included time to hemostasis and blood loss during hemostasis. Visual analog scales (VAS) were used to record subjective data by the operating surgeon including bleeding following adenoid pack removal (0 = none, 3 = brisk) and ease of operation (1 = extremely easy, 6 = extremely difficult). Parents recorded diet on a journal and were contacted by phone at postoperative day 7 and questioned with regard to return to regular diet and use of narcotics.
Results:
Compared to patients in the cautery group (n = 35), Floseal patients (n = 35) had significantly shorter times to hemostasis (0.6 +/- 1.3 minutes vs 9.5 +/- 5.4 minutes [mean +/- SD], P < 0.001), less blood loss (2.5 +/- 9.2 mL vs 29.4 +/- 27.1 mL, P < 0.001), less subjective bleeding (0.0 +/- 0.6 vs 2.0 +/- 0.7, [median 4-point VAS +/- SD], P < 0.001), and subjectively easier operations (2.6 +/- 1.0 vs 5.2 +/- 1.0 [mean 6-point VAS +/- SD], P < 0.001). Furthermore, Floseal patients returned to regular diet earlier (2.7 +/- 0.7 vs 4.1 +/- 0.5 days [mean +/- SD], P < 0.001) and had less use of narcotics at 7 days postoperatively (40% vs 69%, P < 0.05). Lastly, three patients in the cautery group were crossed over to the Floseal group, but no Floseal subjects were crossed over to the cautery group. The retail cost of Floseal is US 85 dollars. Operating room costs are estimated at US 12 dollars/minute. Reducing the operative length by 8.9 minutes on average produces a cost savings of US 106.80 dollars per operation. There were no complications in either experimental group including postoperative hemorrhage, hospitalization, blood transfusion, or aspiration.
Conclusions:
Floseal matrix hemostatic sealant is a safe, efficacious, easy, and cost-effective technique for obtaining hemostasis in children undergoing adenoidectomy. Limitations of the study include the fact that it is nonblinded, which does allow for some bias in the subjective data recorded. However, utilizing 4 different operating surgeons, 3 of whom were not affiliated with the study, minimized this. CLINICAL SIGNIFICANCE OF STUDY: This study demonstrates the safety and efficacy of a novel hemostatic sealant in children undergoing adenoidectomy. Floseal matrix hemostatic sealant can be used as a first-line hemostatic agent, and it is a good tool in the armamentarium of otolaryngologists who encounter significant bleeding following adenoidectomy.