Use of Chitosan Powder in Loop Electrosurgical Excision Procedure
Status:
Recruiting
Trial end date:
2023-09-29
Target enrollment:
Participant gender:
Summary
Early treatment of cervical intraepithelial neoplasia (CIN) II-III gives rise to a decrease
in the incidence of invasive cervical cancer. Though there is no obvious consensus from
randomized studies as to the optimal management of CIN II-III, loop electrosurgical excision
procedure (LEEP) is the most extensively used method because of its technical ease,
inexpensive, steep learning curve, and low rate of complications.
In spite of these benefits, current literature suggests that some patients experience some
complications such as postoperative vaginal bleeding, abnormal vaginal discharge, abdominal
pain, and infection. These adversely affect the recovery period, increase patient anxiety,
readmission to the hospital for further treatment and encumber patients' daily life.
Postoperative vaginal bleeding (PVB) is one of the most common and unpleasant of these
complications. Its incidence has been reported to vary between 2% to 78%.
Many different types of treatments have been applied to avert or diminish PVC such as the use
of vasopressin, tranexamic acid, Monsel's solution, and local hemostats (e.g., TachoSil or
Tisseel), but these attempts have failed to show precise benefits over routine clinical
approaches. Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic,
non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin.
Due to its molecular characteristics, chitosan has been used for improved hemostasis.
Furthermore, chitosan has an antimicrobial and wound-healing effect. The current literature
concerning the influence of using chitosan after the LEEP is limited to only one trial. The
authors of that study reported that using chitosan after the LEEP can reduce vaginal bleeding
and enhancing wound healing. However, that study has some limitations. Therefore,
investigators designed this randomized trial to assess the effect of local chitosan
implementation on postoperative vaginal bleeding and wound healing in LEEP