Clinical Trial: Closure of Skin in ChorioAmnionitis Research Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Closure of Skin in ChorioAmnionitis Research Pilot Study

Brief Summary:

The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions.

The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.


Detailed Summary:
Sponsor: University of British Columbia

Current Primary Outcome: Patient recruitment rate [ Time Frame: 1 year ]

The patient recruitment rate will be calculated as the total number of women successfully recruited to the trial divided by the total duration of the trial.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Follow-up rates [ Time Frame: 6 months post-operative ]
    Number of women successfully contacted at 6 weeks and at 6 months post-partum divided by the total number of women randomized in the trial
  • Wound infection [ Time Frame: 6 months post-operative ]
    Number of women who experience a wound infection divided by the total number of eligible women who participate in the trial.
  • Wound disruption [ Time Frame: 6 months post-operative ]
    Number of women who experience a wound disruption divided by the total number of eligible women who participate in the trial.
  • Wound cosmesis [ Time Frame: 6 months post-operative ]
    Wound cosmesis will be assessed using the POSAS Observer scale, which is directed at physicians, and the POSAS Patient scale, which is directed at patients
  • Patient satisfaction [ Time Frame: 6 months post-operative ]
    Using the POSAS Patient Scale, patient satisfaction will be assessed.
  • Participation rate [ Time Frame: 1 year ]
    The trial participation rate will be calculated as the percentage of eligible women who agreed to participate in the trial divided by the total number of eligible women approached to participate in the trial.


Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: October 31, 2013
Date Started: February 2014
Date Completion: December 2019
Last Updated: May 11, 2017
Last Verified: May 2017