Delayed Primary Closure of Skin in Emergency Caesarean Section

NCT04587960 | Completed

• 1 other identifier: ECR/771/Inst/WB/2015/RR-18
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Wound Disruption; Cesarean Section; Infection

Outcome Measures

Primary Outcomes (1)

• Surgical site infections requiring secondary closure

  Incidence of surgical site infections requiring secondary closure

  6 days from the day of surgery

Secondary Outcomes (1)

• Prolonged hospital stay

  more than 7 days after surgery

Study Arms (2)

Primary closure of Cesarean wound

ACTIVE COMPARATOR

Immediate closure of skin incision where healing occurs by primary intention

Procedure: Primary closure of skin incision in Caesarean section in active comparator group

Delayed primary closure of Cesarean wound

EXPERIMENTAL

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

Interventions

Delayed primary closure of skin incision in Caesarean section in experimental group PROCEDURE

Delayed closure of skin wound of emergency Caesarean section following wound dressing for 2-3 days in experimental group

Delayed primary closure of Cesarean wound

Primary closure of skin incision in Caesarean section in active comparator group PROCEDURE

Primary closure of skin wound (incisional) at the time of emergency Caesarean section in active comparator group

Primary closure of Cesarean wound

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Pregnant mothers undergoing emergency caesarean sections
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parturients admitted with rupture of membranes undergoing emergency CS

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr.Jhuma Biswas: lead

Study Sites (1)

Calcutta National Medical College and Hospital

Kolkata, West Bengal, 700047, India

Location

MeSH Terms

Conditions

Infections

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jhuma Biswas, MBBS, MS

  Dept. of Obstetrics and Gynecology, Calcutta National Medical College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Dept. of Obstetrics and Gynecology, Calcutta National Medical College and Hospital

Model Details: Patients were randomized to delayed primary closure (group A, n=40) or primary closure (group B, n=30)

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 14, 2020
• Study Start: March 1, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)