Safety and efficacy of the chitosan covered tamponade for the management of lower genital tract trauma during childbirth.

Objective: This retrospective analysis evaluates the safety and efficacy of the vaginal use of the chitosan covered gauze ("Celox^™ PPH") in managing lower genital tract trauma with high blood loss, where conventional repair failed.

Methods: Data from patients receiving chitosan covered gauze intravaginally or locally at the vulva due to substantial blood loss because of birth injury were examined retrospectively, using data from a university hospital 2017-2024. Parameters included blood loss, anesthesia, transfusions, length of hospitalization, infection signs, need for intensive care, and tamponade success, defined as bleeding cessation within 5 min and no requirement of further operative intervention.

Results: Use of chitosan covered gauze effectively controlled bleeding in 26 severe birth injury cases except one. Seven women presented with bleeding due to vaginal tears, 2 with cervical tears, 14 with combined vaginal and perineal or cervical tears, 2 with clitoral lacerations and one with a paravaginal hematoma. In the single unsuccessful case the tamponade was applied late after initial suturing because of under-estimated blood loss, and a second subsequent surgery became necessary. In two women of the cohort the gauze was initially used as a bridging concept because of reduced surgical visibility. Median blood loss in the study cohort was 1000 ml resulting in a median hemoglobin-reduction of 3.65 g/dl. Four patients required blood transfusion and intensive care after the bleeding event. Tamponade application duration varied, ranging from 20 min to 24 h, with a median duration of 8.5 h. The median hospital stay was 3 days. Infection parameters were not elevated after gauze application, with no reported cases of postpartum fever nor signs of infection. Removal was uneventful in all patients, expulsion did not occur. Three successful pregnancies after the event have been reported so far.

Conclusion: Vaginal insertion of chitosan covered gauze proved to be safe and effective for the management of severe lacerations after vaginal birth in our retrospective cohort. Shorter application time may be sufficient for birth injuries.