An interventional study of Suture closure and Staples closure in Chorioamnionitis, Pregnancy Complications, Infectious and Complications; Cesarean Section, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2017-05-12.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's planned enrollment of 60 is below the median of 157 across 22 interventional studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Closure of skin with a running subcuticular, absorbable monofilament suture.
Procedure: Suture closure
Closure of skin with stainless-steel surgical staples.
Procedure: Staples closure
A running subcuticular suture is placed by taking horizontal bites through the papillary dermis on alternating sides of the wound. An absorbable suture is used and left in place until degraded and absorbed by the patient's tissues.
Also known as: 3-0 Monocryl suture (from Ethicon)
Surgical stapling devices re-appose skin edges with stainless steel or titanium staples. A second operator everts the wound skin edges while the operator applies staples along the incision. Staples can be removed on post-operative day 2 or 3, or delayed further according the surgeon preference based on patient characteristics.
Patient recruitment rate
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.
Time frame: 1 year
Follow-up rates
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
Time frame: 6 months post-operative
Wound infection
Number of women who experience a wound infection divided by the total number of eligible women who participate in the trial.
Time frame: 6 months post-operative
Wound disruption
Number of women who experience a wound disruption divided by the total number of eligible women who participate in the trial.
Time frame: 6 months post-operative
Wound cosmesis
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
Time frame: 6 months post-operative
Patient satisfaction
Using the POSAS Patient Scale, patient satisfaction will be assessed.
Time frame: 6 months post-operative
Participation rate
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.
Time frame: 1 year
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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