We had an amazing time attending the RCM conference this year and launching our brand Maternity by Kimal. It was fantastic to speak to all the midwives and medical professionals who share our passion for advancing maternal healthcare and for helping to provide perinatal support for all mothers when it’s most needed. Besides getting to meet and talk to you all, our highlight of the conference was the symposium that we hosted about our CELOX™ PPH solution.
We were so happy with the level of engagement that we saw, which was so high that our expert panel didn’t have the time to answer all the questions that were asked. However, during the RCM conference, several important questions about CELOX™ PPH were frequently asked. Below, we’ve compiled clear answers to those questions:
Step 1 – Absorbs fluid from the blood to create a robust gel, which seals the site of bleeding, independently of the body’s natural clotting cascade.Step 2 – Develops mucoadhesive properties to the tissue surrounding the site of bleeding, maintaining the gel plug in place and minimising re-bleed during movement of the patient.Step 3 – Attracts anionic red blood cells to the site of bleeding creating a conducive environment for the body’s natural clotting cascade.Step 4 – Maintains gel plug in place whilst natural clot forms and then naturally breaks down through enzyme degradation (lysozyme) into glucosamine, which is excreted from the body.
CELOX™ PPH should be used when postpartum haemorrhage does not respond to initial management such as uterine massage, volume replacement, and standard medical treatment with uterotonic and antifibrinolytic agents.
Tear open the package at the tear notches. Sterile technique should be observed in delivering the sterile CELOX™ PPH to the field of application.
Use a speculum and an atraumatic instrument to grasp the cervix and manually insert the unfolding CELOX PPH into the uterine cavity up to the uterine fundus. Use ultrasound guidance, if available, to guide application to ensure the device reaches the site of bleeding and to minimise the risk of damaging the uterine wall. If ultrasound is not available, use external manual palpation.
Use a maximum of two CELOX™ PPH per patient over the course of treatment.
Do not cut or tear CELOX™ PPH prior to application as this could increase the risk of material fragments being left in the uterus to avoid injury to the uterine wall.
Use ultrasound, if available, to confirm CELOX™ PPH has reached the site of bleeding. If ultrasound is not available, use external manual palpation.
If needed, the vagina may be packed with secondary sterile dressings/gauze (non CELOX™ PPH) for compression of ascending vessels.
No more than 24 hours.
CELOX PPH can be used after a c-section. Ensure the uterotomy is closed prior to applying CELOX™ PPH transvaginally.
CELOX™ PPH is not approved for intravaginal use, and this type of use is off label.
CELOX™ PPH can be used alongside uterotonic agents.
CELOX™ PPH can be used alongside compression suturing e.g. B-Lynch sutures. Ensure the sutures are applied prior to applying CELOX™ PPH to avoid excessive compression by the procedure resulting in difficulty to remove CELOX™ PPH following treatment completion.
CELOX™ PPH can be used in cases of placenta previa and placenta accreta providing that all contraindications have been ruled out.
Our research has shown no risk that the use of CELOX™ PPH will result in allergic response when used as a topical haemostatic agent. The rigorous manufacturing stages to produce shellfish derived chitosan used in CELOX™ PPH denatures and removes protein (tropomyosin) which is the likely cause of shellfish allergic reactions.
Ensuring proper placement of CELOX™ PPH is crucial for the effective control of uterine bleeding. The following steps are recommended to ensure accurate placement:Use a-traumatic forceps to gently pack the gauze into the uterine cavity and up to the fundusuntil resistance is encountered.Use abdominal palpation to assess the uterus and confirm that the CELOX™ PPH gauze isreaching the fundus by feeling for resistance or the presence of the gauze in the upper part of the uterine cavity.If available, use ultrasound imaging to visualise the position of the CELOX™ PPH gauze withinthe uterine cavity. This not only aids in confirming its position but also facilitates any necessary adjustments, ensuring optimal placement up to the fundus.In the event of persistent difficulty, consider packing a second CELOX™ PPH gauze into the uterine cavity, until resistance is encountered. Leave sufficient length of the end of each CELOX™ PPH protruding through the cervix and vagina to allow subsequent removal.
For optimal insertion of CELOX™ PPH, the following steps are recommended:Use a-traumatic forceps and wrap the CELOX™ PPH gauze around the tip of the forceps,ensuring the edges are neatly folded inward.Apply a small amount of blood from the vaginal area to the surface of the CELOX™ PPH gauzeedges to soften for entry.
The timing of removal OF CELOX™ PPH can be influenced by the successful control of bleeding and the patient’s overall condition, as determined through comprehensive assessments. This includes:
It is advised to conduct routine follow-up procedures post-removal.
Our clinical experts suggest that CELOX™ PPH is generally well tolerated by patients with less pain while in situ within the uterine cavity, and its removal can typically be accomplished without the need for anaesthesia.
CELOX™ PPH has demonstrated its effectiveness through widespread adoption by clinicians in German hospitals for the treatment of uterine postpartum haemorrhage for over 12 years. Professor Wolfgang Henrich of Charite Hospital, Berlin has developed a PPH treatment algorithm, providing invaluable guidance for incorporating CELOX™ PPH into local protocols. This resource (as referenced on figure 6, page 15 of the CELOX PPH Clinical and Scientific Monograph) proves particularly beneficial for clinicians new to the product. For more information on users in specific locations, please feel free to contact us directly.
CELOX™ PPH users experience success rates ranging from 95.6% to 100%. Numerous papers have been published in leading OBGYN journals supporting the use and efficacy of CELOX™ PPH, as follows:Schmid BC, Rezniczek GA, Rolf N, Saade G, Gebauer G, Maul H (2013) ‘Uterine packingwith chitosan-covered gauze for control of postpartum hemorrhage’, AmericanJournal of Obstetrics and Gynecology, Vol. 209 (e1-5), pp. 225.Carles G, Dabiri C, Mchirgui A, Saoudi EO, Hcini N, Pouget K, Seve B, de Matteis B (2017)‘Uses of chitosan for treating different forms of serious obstetrics hemorrhages’. Journal of Gynecology Obstetrics and Human Reproduction, Vol 46 (9), pp. 693-695.Dueckelmann AM, Hinkson L, Nonnenmacher A, Siedentopf JP, Schoenborn I,Weizsaecker K, Kaufner L, Henrich W, Braun T (2019) ‘Uterine packing withchitosan-covered gauze compared to balloon tamponade for managing postpartum hemorrhage’, European Journal of Obstetrics & Gynecology and Reproductive Biology, Vol. 240, pp. 151-155.Biele C, Radtke L, Kaufner L, Hinkson L, Braun T, Henrich W, Dückelmann AM (2022)‘Does the use of chitosan covered gauze for postpartum hemorrhage reduce the need for surgical therapy including hysterectomy? A databased historical cohort study’, Journal of Perinatal Medicine, Vol. 50, (8), pp. 1078-1086.Dueckelmann AM (2022) ‘CELOXTM GAUZE Post-Partum Hemorrhage RetrospectiveData Analysis Report – October 2016 to June 2018′ (2022) Unpublished.
Thank you to all who contributed thoughtful questions during our RCM symposium. This helps to show the continually growing enthusiasm for advancing maternal care, and we hope this Q&A has provided helpful insights into CELOX™ PPH’s role in postpartum haemorrhage management.
To learn more about CELOX™ PPH download a product brochure or get in touch to book a demo.