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CTRI Number  CTRI/2020/06/025555 [Registered on: 02/06/2020] Trial Registered Prospectively
Last Modified On: 01/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare staples non dissolvable sutures versus subcuticular dissolvable sutures for skin closure in caesarean section 
Scientific Title of Study   Comparison of staples versus subcuticular sutures for skin closure in caesarean section-A Randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShafaq Bhandari 
Designation  PG Student Department of Obstetrics and Gynaecology 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  room number 308 type 1 quarters AIIMS residential complex AIIMS, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9878828814  
Fax    
Email  shafaq192@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manu Goyal 
Designation  Associate Proffessor, Department of Obstetrics and Gynaecology 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  AIIMS residential complex AIIMS JODHPUR

Jodhpur
RAJASTHAN
342005
India 
Phone  9878828814  
Fax    
Email  drmanu_8@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Shafaq Bhandari 
Designation  PG Student Department of Obstetrics and Gynaecology 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  room number 308 type 1 quarters AIIMS residential complex AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9878828814  
Fax    
Email  shafaq192@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  Phase 2 Basni Jodhpur 
Type of Sponsor  Government 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 
shafaq bhandari  AIIMS Jodhpur  Department of obstetrics and gynecology AIIMS Jodhpur
Jodhpur
RAJASTHAN 
9878828814

shafaq192@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  metallic surgical skin staplers  subcuticular sutures vs metallic skin staplers for skin closure in cesarean section 
Comparator Agent  subcuticular sutures  subcuticular sutures vs metallic skin staplers for skin closure in cesarean section 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Women with viable pregnancies (≥ 26 weeks) undergoing caesarean delivery at AIIMS, Jodhpur.

2. All caesarean types will be included - scheduled or unscheduled and primary or repeat caesareans with low transverse/ Pfannenstiel incision
 
 
ExclusionCriteria 
Details  1. Inability to obtain informed consent
2. Immune compromising disease (e.g. AIDS)
3. Chronic steroid use
4. Contraindication to routine postpartum pain medications (ibuprofen,narcotics) eg in CKD patient
5. Chorioamnioinitis
6. Caesarean section done by vertical incision.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To compare the rate of wound complication by 6 weeks post operatively following metallic surgical stapler vs subcuticular sutures for skin closure after caesarean delivery

 
day 3 post op
6 weeks post op
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the pain score post operatively on day 3 and after 6 weeks between metallic surgical staples and subcutaneous sutures skin closure after caesarean delivery
2.To compare the skin closure time between the two groups
3. To compare patient satisfaction rates between the two groups

 
day 3 post op
6 weeks post op 
 
Target Sample Size   Total Sample Size="289"
Sample Size from India="289" 
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 3 
Date of First Enrollment (India)   04/06/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Caesarean section is the most common surgery performed worldwide. Currently, approximately 15 % of pregnant women worldwide deliver by caesarean, and this prevalence is on the rise.​1,9.​A great variety of materials and techniques are used for skin closure after caesarean section and there is a need to identify which provide the best outcomes for women. Skin closure can be carried out with stitches that go under the skin and stitches that go over the skin or staples /clips. Suture materials currently available are natural or synthetic, absorbable or non-absorbable, single-filament or braided. Staples are attractive because of the speed of application.7Two methods of skin closure used frequently in routine practice are metallic surgical staples and absorbable subcuticular sutures. The method chosen relies on the surgeon’s preference. There is not enough evidence from the included studies to say which method of closing the caesarean skin incision is superior.The impact of these methods on postoperative pain, skin closure time, aesthetic results, wound dehiscence and infections remain controversial.​2​Wound complications following caesarean delivery result in significant morbidity.8Wound complication, including infection, separation, and fluid collection, is an expensive complication and poses a significant burden to the patient, affecting 3% - 16% of patients undergoing caesarean6. Therefore, it is of importance to determine the most effective and safest closure method with which to decrease patient morbidity. There exists in the literature a longstanding debate regarding the superiority of primary suture versus staple closure in terms of wound complication, closure time and aesthetics.It is postulated the sutures act as foreign material and cause tissue damage, increasing the risk of infections.​The use of prophylactic antibiotics to reduce infection was not reported in most trials.3, 7 Wound complications include wound infection, discharge, gaping, disruption, hematoma formation, seroma formation and wound dehiscence.

Initial small studies regarding caesarean skin closure materials examined operative time, pain scores, cosmesis scores and/or patient satisfaction and yielded contradictory findings.​4, 5​One randomized controlled trial of wound disruption or infection(evaluated by phone interview supplemented with record review) at 2-4 weeks as the primary outcome, suggested increased rates with staple as compared to suture closure.​6​Studies have also compared other parameters between different skin closure techniques. These are suturing time, post op pain, patient satisfaction arte and cosmetic appearance of skin. Given the paucity of trials that adequately examined wound complication outcomes of skin closure methods in caesarean delivery, we propose a study to compare wound complicationrates between surgical staples and the subcutaneous suturesfor skin closure in caesarean section. We will also compare other parametersincluding skin closure time, postoperative pain and patient satisfaction rate between the two techniques used for skin closure.

 
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