A study to compare staples non dissolvable sutures versus subcuticular dissolvable sutures for skin closure in caesarean section
- Conditions
- Other complications of obstetric surgery and procedures,
- Registration Number
- CTRI/2020/06/025555
- Lead Sponsor
- AIIMS JODHPUR
- Brief Summary
Caesarean section is themost common surgery performed worldwide. Currently, approximately 15 % ofpregnant women worldwide deliver by caesarean, and this prevalence is on therise.​1,9.​A great variety of materials andtechniques are used for skin closure after caesareansection and there is a need to identify which provide the best outcomesfor women. Skin closure can be carried out with stitches that go under the skinand stitches that go over the skin or staples /clips. Suture materialscurrently available are natural or synthetic, absorbable or non-absorbable,single-filament or braided. Staples are attractive because of the speed ofapplication.7Two methods of skin closure used frequently in routinepractice are metallic surgical staples and absorbable subcuticular sutures. Themethod chosen relies on the surgeon’s preference. There is not enough evidencefrom the included studies to say which method of closing the caesarean skinincision is superior.The impact of these methods on postoperative pain, skinclosure time, aesthetic results, wound dehiscence and infections remaincontroversial.​2​Wound complications following caesareandelivery result in significant morbidity.8Wound complication,including infection, separation, and fluid collection, is an expensivecomplication and poses a significant burden to the patient, affecting 3% - 16%of patients undergoing caesarean6. Therefore, it is of importance todetermine the most effective and safest closure method with which to decreasepatient morbidity. There exists in the literature a longstanding debateregarding the superiority of primary suture versus staple closure in terms of woundcomplication, closure time and aesthetics.It is postulated the sutures act asforeign material and cause tissue damage, increasing the risk of infections.​The use of prophylactic antibioticsto reduce infection was not reported in most trials.3, 7 Woundcomplications include wound infection, discharge, gaping, disruption, hematomaformation, seroma formation and wound dehiscence.
Initial small studiesregarding caesarean skin closure materials examined operative time, painscores, cosmesis scores and/or patient satisfaction and yielded contradictoryfindings.​4, 5​One randomized controlled trial ofwound disruption or infection(evaluated by phone interview supplemented withrecord review) at 2-4 weeks as the primary outcome, suggested increased rateswith staple as compared to suture closure.​6​Studies have alsocompared other parameters between different skin closure techniques. These aresuturing time, post op pain, patient satisfaction arte and cosmetic appearanceof skin. Given thepaucity of trials that adequately examined wound complication outcomes of skinclosure methods in caesarean delivery, we propose a study to compare wound complicationratesbetween surgical staples and the subcutaneous suturesfor skin closure in caesareansection. We will also compare other parametersincluding skin closure time, postoperativepain and patient satisfaction rate between the two techniques used for skinclosure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 289
-
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
AIIMS Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
AIIMS Jodhpur🇮🇳Jodhpur, RAJASTHAN, Indiashafaq bhandariPrincipal investigator9878828814shafaq192@gmail.com