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
|
|
Primary Sponsor
|
Name |
AIIMS JODHPUR |
Address |
Phase 2 Basni
Jodhpur |
Type of Sponsor |
Government 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 |
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
|
|
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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