Hemostasis of oral surgery wounds with the HemCon Dental Dressing.

PURPOSE: This study evaluated the efficacy of the HemCon Dental Dressing (HDD; HemCon Medical Technologies, Inc, Beaverton, OR) hemostatic oral wound dressing derived from the US military HemCon Bandage combat wound dressing and whether early hemostasis affects postoperative care and surgical healing outcomes following oral surgical procedures. PATIENTS AND METHODS: All patients aged 18 to 90, except those allergic to seafood, who consented to participate were eligible for enrollment into this study regardless of other medical history findings. All patients were required to have 2 or more surgical sites so they would have internal surgical control sites. All patients taking oral anticoagulation therapy (OAT) were included for treatment in this study without altering their anticoagulant medication regimens. All data were evaluated by biomedical statisticians and Institutional Review Board approval was obtained. RESULTS: All HDD surgically treated sites, including all from patients taking OAT, achieved hemostasis in less than 1 minute and control wounds in 9.53 minutes (P < .001). All HDD sites achieved hemostasis sooner than control sites (P <.001). Approximately 32% of HDD treated sites had significantly better healing compared with control sites (P <.020) and no control sites healed better than HDD treated sites; 32% of HDD treated oral surgery wounds achieved statistically significant improved healing (P <.001). All patients taking OAT achieved hemostasis within 1 minute and were treated without altering their anticoagulant regimens. Although the pain scores and incidence of alveolar osteitis were lower for the HDD-treated sites, these scores were not significantly different than control-treated sites. There was no negative healing sequela associated with early hemostasis of oral surgical wounds. CONCLUSION: The HDD has been proven to be a clinically effective hemostatic device that significantly shortens bleeding time following oral surgery procedures for all patients, including those patients taking OAT. Patients receiving the HDD had improved surgical wound healing compared with those receiving controls.

Doxepin rinse for management of mucositis pain in patients with cancer: one week follow-up of topical therapy.

This study assessed the effectiveness of oral doxepin rinse for mucositis-related pain management in patients following 1 week of repeated dosing. Patients with oral mucositis due to head and neck radiation therapy or hematopoietic stem cell transplant (HSCT) were recruited to participate in a 1-week follow-up study. Subjects who gave informed consent rinsed with doxepin (5 ml) during the initial visit and were then told to use doxepin rinse over the next week as needed, three to six times per day, and return for a follow-up visit. At each visit, mucositis was scored using the Oral Mucositis Assessment Scale and oral pain was assessed using a visual analogue scale before and after rinsing. The use of a systemic analgesic was recorded, and side effects were documented. At the follow-up visit, subjects were also asked to retrospectively report average pain scores they experienced over the past week, 5 and 15 minutes following rinse. Nine subjects were enrolled in the study. Statistically significant reductions in pain scores were reported for 2 hours following doxepin rinse during the initial visit (p < .05). Patients recalled that their pain significantly dropped within 5 minutes of rinsing over the week of repeated dosing (p < .05). At the follow-up visit, subjects reported statistically significant pain reduction 5 minutes after doxepin rinsing (p < .05). These results indicate that doxepin rinsing continues to produce reduced intensity of pain levels over a 1-week span of repeated dosing.

Oral doxepin rinse: the analgesic effect and duration of pain reduction in patients with oral mucositis due to cancer therapy.

This research expands on our prior study, in which we assessed pain reduction after topical doxepin rinse in patients with oral mucositis resulting from cancer and cancer therapy. We continued to enroll patients with painful oral mucositis attributable solely to cancer therapy and performed further analysis on the duration of pain reduction. Fifty-one patients with oral mucositis were enrolled. Mucositis was scored and oral pain was assessed with a visual analog scale before doxepin oral rinse (5 mg/mL) and at regular intervals up to 4 h after rinsing. Of those who reported pain reduction, 95% did so within 15 min of rinsing with doxepin. In the total sample, the average patient reported a 70% maximum decrease in pain (P < 0.0001). Recurrence of pain was slow and at the conclusion of the study 19 patients (37%) still reported a reduction from baseline pain. With this censored data we used Cox-proportional hazards to determine what variables best explained longer duration of pain reduction. Our final model determined that more severe baseline pain, worse mucosal erythema score, or a larger relative maximum reduction in pain were all associated with a slower rate of pain recurrence after oral rinsing (all P < 0.01).

Oral topical doxepin rinse: anesthetic effect in normal subjects.

Oral doxepin rinse has been reported to provide pain relief in patients with oral mucosal lesions due to cancer or cancer therapy. The purpose of this study was to assess the anesthetic effect of doxepin oral rinse in normal subjects to identify the duration of effect and to contrast the anesthetic effect with reported pain relief in patients with oral mucosal lesions. Normal volunteers were provided a solution of doxepin (5 mg/mL) for oral rinsing. Oral numbness and adverse effects were recorded for a period of 4 h after rinsing. Doxepin rinse resulted in mucosal anesthesia in all subjects. Sedation/fatigue was reported in four of seven subjects. There were no taste complaints and no nausea reported. The limited duration of numbness/anesthesia in normal subjects compared with prior studies showing pain relief for more than 3 h in patients with mucosal lesions, suggests that the extended duration of pain relief in patients was due to analgesic effects rather than anesthetic effects. The majority of normal subjects reported sedation after use, but this was less common in patients with mucosal lesions.