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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).

 
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