Hemostatic Matrix for Managing Pediatric Vaginal Trauma Subsequent to Straddle Injury

Introduction

Accidental trauma to the vulva and vagina during childhood is most commonly caused by straddle injuries. Straddle injuries occur when a girl falls and strikes the urogenital area on an object with the force of her body weight. ¹ Injuries are typically unilateral and superficial. Most injuries are hematomas or lacerations of the mons pubis, clitoral hood, and labia minora. ¹ These injuries are sometimes amenable to expectant management and may require only a follow-up visit. ² However, studies from pediatric referral centers suggest that up to 50% of straddle injuries result in surgical or gynecologic consultation. ³ Many children with injuries suspect for deep laceration of the hymen or pelvic floor or urethral disruption will appropriately undergo operation. ³ In cases when examination is difficult, such as younger children, surgery is more frequently performed. ³ However, not all injuries require exploration, and the risk of complications is not negligible. There is risk of physical trauma and further hemorrhage in trying to obtain exposure, anesthetic risk, potential psychological distress to the patient and parents, and operating room expense.

In prepubertal girls, patient size and distress can preclude an adequate gynecologic examination, and general anesthesia is often necessary if there is a question of unrecognized penetrating trauma. However, to avoid the risks of surgical intervention and anesthesia, less invasive treatments may be considered in patients at low risk for serious internal trauma. Topical application of fibrin sealants and hemostatic matrix products have been reported to be useful in adults in controlling complications of hemorrhage and tissue breakdown in several obstetric and gynecologic settings.^4–6 In the pediatric population, hemostatic matrix has been used for hemostasis in adenotonsillectomy and adenoidectomy procedures.^7,8 A novel use of a hemostatic matrix (FLOSEAL, Baxter Healthcare Corporation, Hayward, CA) that has not been previously described in the literature, which successfully arrested further vaginal bleeding in a prepubertal girl who sustained accidental genital trauma from a straddle injury, is presented.

Case

A 2-year-old female was brought in by her parents to the emergency department after sustaining a straddle injury. The girl had been playing and bathing in a washbasin when she slipped and fell in such a fashion that her perineum hit the tub edge. The patient presented as fussy, but consolable, with stable vital signs. Normal laboratory tests included a complete blood count and coagulation studies. The patient's abdomen was benign. While the patient was in the butterfly position, an examination of the external genitalia demonstrated a 1-cm superficial, linear left abrasion to the labia minora extending to the vagina, with surrounding ecchymosis and mild bleeding. The upper extent of the laceration was not fully visible. The vaginal vestibule showed some pooling of blood. The anal sphincter, urethral meatus, hymen, and posterior fourchette were intact, and no hematomas were visualized. A vaginal examination was attempted with gentle labial separation and traction; however, because of patient's size and discomfort, it was difficult to ascertain the complete site and extent of bleeding. Upon further questioning, the history and physical findings remained consistent with accidental genital trauma and not sexual abuse. There was little suspicion of penetrating trauma. The parents subsequently gave consent for the patient to be examined under anesthesia; however, the surgery was delayed for 4 hours because of the timing of patient's last meal. During the interim, signs of vaginal bleeding resolved and the patient was able to void without difficulty. The patient was discharged home in stable condition with recommendations for limited activity and close follow-up.

Two days later the patient returned to the emergency department with recurrence of vaginal bleeding. The mother stated that her daughter had been cheerful and active as usual upon discharge until the day of re-evaluation. The girl suddenly bled heavily, soaking two diapers in 4 hours with passage of blood clots. Bowel and urinary function were reported as normal. On physical examination, the patient was pale and fatigued, but in no pain. Vital signs were stable and laboratory tests were significant for a hemoglobin of 9.7 g/dL, decreased from 12.1 2 days prior. Pelvic examination showed healing left of the labia minora laceration, but brisk vaginal bleeding. Again, limited examination of the perineum did not confirm the upper extent of the source of bleeding.

Pediatric surgery and gynecology services were consulted and both agreed to try a topical hemostatic matrix (FLOSEAL, Baxter Healthcare Corporation, Hayward, CA) for the management of the vaginal bleeding. Detailed consent was also obtained from the parents. Mild sedation with Versed was administered and the hemostatic matrix was extruded from the syringe with an applicator tip, into the girl's vagina. The entire procedure took ∼ 5 minutes from administration of Versed to the application of the product, and was performed in the examination room.

Results

The patient tolerated the procedure well, and hemostasis was noted within <1 minute. The child was admitted to the pediatric service for observation overnight. Her hospital course was uneventful, and she was discharged the following morning in stable condition with sustained arrest of vaginal bleeding. Three follow-up visits over 2 months revealed good recovery with resolved anemia and no residual bleeding, discomfort, or complications.

Discussion

Pelvic examinations of prepubertal girls who endure straddle injuries can be traumatizing and limited given their smaller, virginal genital anatomy. Rarely, can a complete pediatric gynecologic examination be obtained without conscious sedation or general anesthesia. Straddle injuries, however, are typically superficial, making operative intervention usually unnecessary, unless there is concern for deeper penetrating injury. ² In such cases, vaginoscopy with a 3 mm outer diameter (OD) continuous flow hysteroscope, with the patient under sedation, can be a safe and useful method to assure the site and extent of the vaginal injury. On the other hand, when an unidentified source of bleeding from a straddle injury is noted in an otherwise stable child, the provider can consider a noninvasive and less costly treatment.

FLOSEAL (Baxter Healthcare Corporation, Hayward, CA) hemostatic matrix is a combination of two independent hemostasis-promoting agents, human-derived thrombin and bovine-derived gelatin. Thrombin converts fibrinogen into fibrin monomers, which polymerize to form a mechanically stable clot around the gelatin matrix. The product can be effective for all degrees of bleeding, from oozing to spurting. Control of bleeding occurs within 2 minutes. FLOSEAL is biocompatible and resorbs within 6–8 weeks, consistent with normal wound healing. It works on wet, actively bleeding tissue, within body cavities, and conforms to irregular wound surfaces. ⁹ The hemostatic properties of this product and subsequent use in body cavities make it unlikely that adjacent tissues would adhere improperly prior to resorption. ⁷ Any excess granular material not incorporated into the clot is removed by gentle irrigation. The kit contains mixing accessories and an applicator tip that eases delivery of the substance to hard-to-reach surfaces. These qualities combined make the product an appealing alternative to surgery for treatment of an unidentified, nonpenetrating injury in a prepubertal girl. FLOSEAL is indicated in surgical procedures (other than ophthalmic ones) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Randomized controlled trials have shown the efficacy and safety of this hemostatic agent in a variety of surgical specialties (cardiovascular; ⁷ vascular; ⁸ spinal/orthopedic; ¹⁰ pediatric ear nose, and throat (ENT); ¹¹ and gynecology ¹² ). FLOSEAL should not be used in patients with known sensitivity to materials of bovine origin, nor should it be blindly injected into a vessel or tissue, to avoid the risk of allergic-anaphylactoid reaction, or thromboembolic events.

Conclusions

FLOSEAL has been approved by the United States Food and Drug Administration (FDA) since 1999. ⁹ Although indicated in surgical procedures as an adjunct to hemostasis (other than in ophthalmic surgery), FLOSEAL has been found to be useful in nonoperative settings, that is, management of groin breakdown after inguinal lymphadenectomy for vulvar cancer. ⁵ Our experience with the use of FLOSEAL in controlling bleeding from a prepubertal vagina caused by a nonpenetrating straddle injury illustrates another novel use, to avoid anesthesia and operative management in select girls with appropriate informed consent.