Use of Chitosan Powder in Loop Electrosurgical Excision Procedure

Sponsor

Erzincan Military Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05661708

Collaborator

(none)

230

Enrollment

Locations

Arms

9.5

Anticipated Duration (Months)

115

Patients Per Site

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Vaginal Bleeding Loop Electrosurgical Excision	Drug: Chitosan	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Aug 18, 2023

Anticipated Study Completion Date :

Sep 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. An empty spray pump was used because we cannot find any identical powder for the placebo
Experimental: Chitosan LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. The application of 3 or 4 pumps of chitosan powder was carried out into the wound bed by spray pump which was prepared by a nurse.	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

Arm

Intervention/Treatment

No Intervention: Control

LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. An empty spray pump was used because we cannot find any identical powder for the placebo

Experimental: Chitosan

LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. The application of 3 or 4 pumps of chitosan powder was carried out into the wound bed by spray pump which was prepared by a nurse.

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

Outcome Measures

Primary Outcome Measures

median early postoperative blood loss [24 hours]
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

Secondary Outcome Measures

Wound healing score [6 weeks]
wound healing score was evaluated according to scale (min: 0, max:4)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kemal Güngördük	Menteşe	Muğla	Turkey	48000
2	Mugla Sıtkı Kocman University Education and Research Hospital	Mugla		Turkey	48000

Sponsors and Collaborators

Erzincan Military Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kemal GUNGORDUK, Medical Doctor - Professor, Erzincan Military Hospital

ClinicalTrials.gov Identifier:

NCT05661708

Other Study ID Numbers:

MUGLA-9

First Posted:

Dec 22, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Hemorrhage

Chitosan

Study Results

No Results Posted as of Dec 22, 2022