| CTRI Number |
CTRI/2024/07/070591 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of adhesive and suture in skin closure following small incision abdominal surgery
(laparoscopic) |
|
Scientific Title of Study
|
A comparative study to assess efficacy and safety of suturing versus topical skin adhesive (n-butyl-2-cyanoacrylate) for portsite skin closure in patients undergoing laparoscopic surgery in a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaithanya T N |
| Designation |
Junior Resident |
| Affiliation |
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara |
| Address |
Department Of Obstetrics and Gynecology, Adichunchanagiri
Institute Of Medical Sciences, B.G. Nagara
Mandya
KARNATAKA
571448
India
Mandya KARNATAKA 571448 India |
| Phone |
9972168643 |
| Fax |
|
| Email |
moulya1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mahendra G G |
| Designation |
Professor |
| Affiliation |
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara |
| Address |
Department Of Obstetrics and Gynecology, Adichunchanagiri
Institute Of Medical Sciences, B.G. Nagara
Mandya
KARNATAKA
571448
India
Mandya KARNATAKA 571448 India |
| Phone |
9964026610 |
| Fax |
|
| Email |
drmuba@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mahendra G G |
| Designation |
Professor |
| Affiliation |
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara |
| Address |
Department Of Obstetrics and Gynecology, Adichunchanagiri
Institute Of Medical Sciences, B.G. Nagara
Mandya
KARNATAKA
571448
India
Mandya KARNATAKA 571448 India |
| Phone |
9964026610 |
| Fax |
|
| Email |
drmuba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adichunchanagiri Institute of Medical Sciences, B.G. Nagara 571448 |
|
|
Primary Sponsor
|
| Name |
Adichunchanagiri Institute Of Medical Sciences |
| Address |
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara 571448 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chaithanya T N |
Adichunchanagiri Institute Of Medical Sciences |
Department Of
Obstetrics and
Gynecology
Adichunchanagiri
Institute Of Medical
Sciences, B.G. Nagara
571448
Mandya
KARNATAKA Mandya KARNATAKA |
9972168643
moulya1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Adichunchanagiri Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N-butyl-2-Cynoacrylate |
Topical tissue adhesive for closure of portsite after laparoscopic surgery |
| Comparator Agent |
Triclosan coated polyglactin 910 |
Antimicrobial coated polyglactin 910 suture for closure of portsite after laparoscopic surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients willing to give written informed consent
2. Patients planned for total laparoscopic surgery in the Department of Obstetrics and Gynecology
3. Patients posted for Fibroid, Unresponsive perimenopausal hemorrhage, Adenomyosis, Perimenopausal women with AUB laparoscopic surgeries
|
|
| ExclusionCriteria |
| Details |
1. Known or suspected gynecological malignancy
2. Patients with active pelvic infection
3. Patients with cardio-pulmonary complications
4. Patients unfit for pneumo-peritoneum or Trendelenburg position
5. Patient with known Coagulation disorder
6. Patients who have not given written informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate incidence of surgical site infection using CDC criteria for SSI |
Day of discharge Post-surgery day 10±3 Post-surgery day 30±7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the time required for port closure in both the groups |
Day of surgery |
| To evaluate wound pain using 10-point Visual Analog Scale (VAS) score |
Day of discharge Post-surgery day 10±3 Post-surgery day 30±7 |
To Evaluate ease of application/usage using Product Usage Assessment Scale
(using 5-point scale, with 5 being excellent and 1 being poor) |
Day of surgery |
| To Evaluate patient’s satisfaction in both the groups (using 5-point scale, with 5 being excellent and 1 being poor) |
Day of discharge Post-surgery day 10±3 Post-surgery day 30±7 |
| To evaluate post-operative wound complications in both the groups |
Day of discharge Post-surgery day 10±3 Post-surgery day 30±7 |
| To assess Cosmetic appearance of the wound using Modified Hollander Wound Score |
Day of discharge Post-surgery day 30±7 |
| To evaluate adverse events among the two groups |
Day of discharge Post-surgery day 10±3 Post-surgery day 30±7 |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic surgery has become the standard of care for surgical procedures across multiple specialties, reducing perioperative complications, accelerating recovery and providing superior cosmetic results. Diagnostic and operative laparoscopies are among the most common procedures in gynecology. There is no ‘‘gold standard’’ for the method of wound closure in laparoscopic wounds. A variety of procedures is available such as transcutaneous suture, subcuticular suture, adhesive paper tape, skin staples and skin adhesives. The ideal wound closure material should permit a precise wound closure with reapproximation of wound. Sutures being a classic method of wound closure have many have certain disadvantage namely prolonged duration of surgery and anesthesia, tissue reactivity, risk of needle stick, undesirable trauma to the intact tissue on either side of the wound, permanent suture tracts, early removal which results in dehiscence, anxiety, and pain during removal. Tissue adhesive were invented in 1949 and tried clinically for the first time in 1959, which allows for normal wound healing and is accomplished without the need of local anesthesia or tissue injury. N-butyl-2-cynoacrylate in liquid solution is monomeric, application to tissue results in polymerization, resulting in a strong tissue bond that holds the wound edges together. Advantages of this adhesive over conventional wound closure techniques include easy to use, rapid application, patient comfort, excellent bacteriostatic property, resistant to infection, no risk of needle stick injury, decreased repair time, good hemostasis, eliminates recalled visits and has good short and long-term cosmetic outcome. Though the tissue adhesives were invented in mid 90’s, it is not been used frequently despite its remarkable advantages over traditional suturing, hence the purpose of this study is to compare the outcomes with n-butyl cyanoacrylate (Truseal) versus suturing (Trusynth plus neo). |