Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04587960 |
| Other study ID # |
ECR/771/Inst/WB/2015/RR-18 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
June 15, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Calcutta National Medical College and Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pregnant mothers requiring emergency cs with history of ruptured membranes would be allocated
randomly into two groups in an aim to study the comparative outcome of different methods of
skin closure namely primary and delayed primary closure on the incidence of wound infections
requiring secondary closures and to detect the associated risk factors increasing chance of
surgical site infections.
Description:
OBJECTIVE
• To compare the effect of two different methods of skin wound closure namely Primary Closure
and Delayed Primary Closure on the incidence of wound infection and requirement for secondary
skin wound repair after emergency caesarean section in patients with ruptured membranes.
RESEARCH HYPOTHESIS Caesarean Sections (CS) in emergency situation where amniotic membrane is
ruptured are clean contaminated procedures which are associated with 10-20% wound
disruptions. Delayed Primary Closure for managing contaminated wounds is a concept well
recognized by military surgeons, which reduces wound infections. Investigators wish to
conduct this prospective study to determine the efficacy of using this technique of wound
closure in Caesarean Sections in patients with history of ruptured amniotic membranes.
Investigators wish to study and compare the effect of this technique versus conventional
primary skin closure on wound infection and incidence of secondary wound suturing in CS with
ruptured membranes.
MATERIALS AND METHODS:
1. STUDY DESIGN: Randomized controlled Trial
2. STUDY SETTING: Tertiary teaching hospital-based trial involving obstetric patients
undergoing Caesarean delivery.
3. PLACE OF STUDY: Department of Obstetrics and Gynecology, Calcutta National Medical
College and Hospital, Kolkata.
4. PERIOD OF STUDY: From 1st March 2020 to 15th June 2021.
5. SAMPLE SIZE: As no similar study was found in literature related to obstetric
population, we have chosen an arbitrary sample size of 30 in case group and 30 in
control group in this Pilot study.
6. STUDY POPULATION:
INCLUSION CRITERIA :
• Parturients admitted with rupture of membranes undergoing emergency CS
EXCLUSION CRITERIA :
- Presence of intact membranes
- Incision other than Pfannenstiel
- Presence of pre-existing infection at the site of skin incision
- Presence of obvious chorioamnionitis
- Presence of any immunosuppressive condition including HIV, intake of immunosuppressive
medication, h/o chemotherapy, haematological malignancies, etc.
- Presence of other conditions interfering with wound healing like Tuberculosis, Diabetes,
collagen disorders, etc.
i) PROCEDURE:
Mothers undergoing emergency CS for various indications after rupture of membranes will be
randomly allocated to two groups Study group to undergo Delayed Primary Closure of skin
incision and Control group to undergo Primary closure of skin incision, after appropriate
consenting.
During CS Pfannenstiel incision will be made in the skin. All patients will receive
prophylactic antibiotic within thirty minutes of making abdominal incision. Depending upon
the duration of membrane rupture wound will be defined either contaminated (duration of
membrane rupture ≥ 12 hours) or clean contaminated (duration of membrane rupture ≤12 hours).
At the end of the procedure after closure of rectus sheath in the Study group, interrupted
stitches will be taken through skin and subcutaneous tissue with 1-0 monofilament suture but
knots will not be tightened and skin will be left open. Following operation, from next day
onwards dressing of the wound will be done for 3 days. On 4th day, the monofilament stitches
will be tightened under local anaesthesia to appose the skin. Thereafter, sutures will be
removed on 7th day after operation.
In the Control group wound margins will be apposed by primary closure by interrupted stitches
using 1-0 monofilament and stitches will be removed on 6th day after operation.
If there is abnormal discharge from wound, wound swabs will be taken for bacterial culture
sensitivity test.
If there is wound dehiscence, timing of secondary closure will be decided based on wound
health and presence of adequate granulation tissue after a period of regular wound dressing.
STASTICAL ANALYSIS PLAN Statistical methods- Linear data will be represented a mean ±
standard deviation for normally distributed data and as mean (interquartile range (IQR)) for
not-normally distributed data. Categorical data will represented as percentage (frequency).
Comparison of means will be done with Mann Whitney U test and comparison of proportions with
Chi - squared test or Fisher's exact test as appropriate. Multivariate modeling with logistic
regression will be used to compare different variables between the primary closure and
delayed primary closure groups.
