Use of Chitosan Powder in Loop Electrosurgical Excision Procedure

Vaginal Bleeding Clinical Trial

Official title:

Use of Chitosan Powder in Loop Electrosurgical Excision Procedure to Reduce Postoperative Complications: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661708
• Other study ID #: MUGLA-9
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2022
• Est. completion date: May 17, 2024

Study information

• Verified date: May 2024
• Source: Erzincan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 17, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• women were aged > 21 years old

• women were not pregnant

• women who were undergoing LEEP.

Exclusion Criteria:

• Women with pelvic infection

• Women with abnormal vaginal bleeding

• Women with coagulopathy

• Women with chronic pain syndromes

• Women with psychiatric disorders

• Women with the previous hysterectomy with removal of the cervix,

• Women with a history of cervical cancer

• Women who could not complete follow-up calls

Related Conditions & MeSH terms

• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

Drug:
• Chitosan
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

Locations

Country	Name	City	State
Turkey	Kemal Güngördük	Mentese	Mugla
Turkey	Mugla Sitki Kocman University Education and Research Hospital	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median early postoperative blood loss	early postoperative blood loss using the difference in hematocrit values after LEEP and 24 h after the procedure according to the following formula: estimated blood loss = estimated blood volume × (hematocrit 1 - hematocrit 2) / hematocrit 1, where the estimated blood volume in milliliters = body weight in kilograms × 85	6 hours
Secondary	Wound healing score	The imagine J software program (https://imagej.net/ij/) was used to measure the area of wounds. In order to determine the rate of wound healing, the formula used is [(initial area of treatment wound - remaining wound area)/initial area of treatment wound] × 100%.	1-4 weeks