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Delayed Primary Closure of Skin in Emergency Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587960
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dr.Jhuma Biswas, Calcutta National Medical College and Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Cesarean Wound Disruption Cesarean Section; Infection Procedure: Delayed primary closure of skin incision in Caesarean section in experimental group Procedure: Primary closure of skin incision in Caesarean section in active comparator group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Outcome Between Primary Closure and Delayed Primary Closure of Skin Incision in Emergency Caesarean Section
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Primary closure of Cesarean wound
Immediate closure of skin incision where healing occurs by primary intention
Procedure: Primary closure of skin incision in Caesarean section in active comparator group
Primary closure of skin wound (incisional) at the time of emergency Caesarean section in active comparator group

Experimental: Delayed primary closure of Cesarean wound
Delayed closure of skin incision following regular wound dressing for 2 to 3 days.
Procedure: Delayed primary closure of skin incision in Caesarean section in experimental group
Delayed closure of skin wound of emergency Caesarean section following wound dressing for 2-3 days in experimental group




Primary Outcome Measures :
  1. Surgical site infections requiring secondary closure [ Time Frame: 6 days from the day of surgery ]
    Incidence of surgical site infections requiring secondary closure


Secondary Outcome Measures :
  1. Prolonged hospital stay [ Time Frame: more than 7 days after surgery ]
    Requiring prolonged hospital stay due to wound infection



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant mothers undergoing emergency caesarean sections
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible parturients admitted with rupture of membranes undergoing emergency CS

Exclusion Criteria:

i. Presence of intact membranes ii. Incision other than Pfannenstiel iii. Presence of pre-existing infection at the site of skin incision iv. Presence of obvious chorioamnionitis v. Presence of any immunosuppressive condition including HIV, intake of immunosuppressive medication, h/o chemotherapy, haematological malignancies, etc.

vi. Presence of other conditions interfering with wound healing like Tuberculosis, Diabetes, collagen disorders, etc.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587960


Contacts
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Contact: Jhuma Biswas, MBBS, MS +919433019780 drjhumabiswas78@gmail.com

Sponsors and Collaborators
Dr.Jhuma Biswas
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Responsible Party: Dr.Jhuma Biswas, Dr. Jhuma Biswas, Calcutta National Medical College and Hospital
ClinicalTrials.gov Identifier: NCT04587960    
Other Study ID Numbers: ECR/771/Inst/WB/2015/RR-18
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD would be used for this study only

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes