Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

• Sponsor: Michael Stitely (Other)
• Overall Status: Completed
• CT.gov ID: NCT01755026
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery.It is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level.These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery; Wound Infection; Obesity	Drug: cefazolin; Drug: cefazolin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 gram dose of cefazolin 2 gram dose of pre-operative cefazolin	Drug: cefazolin; 2 gram dose for pre-operative prophylaxis; Other Names: Ancef
Experimental: 4 gram Dose 4 gram dose of pre-operative prophylaxis	Drug: cefazolin; 4 gram dose for pre-operative prophylaxis; Other Names: Ancef

Outcome Measures

Primary Outcome Measures

1. Cefazolin Levels [2 hours]

   Cefazolin levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 years or above

2. Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit

3. Undergoing cesarean delivery

Exclusion Criteria:

1. BMI less than 35.

2. Not undergoing Cesarean delivery.

3. Age less than 18 years.

4. Pre-existing infection.

5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.

6. Cesarean delivery being performed under emergent circumstances.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University Hospital	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• Michael Stitely

Investigators

• Principal Investigator: William H Holls, MD, West Virginia University
• Study Chair: Michael L Stitely, MD, West Virginia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
• ClinicalTrials.gov Identifier: NCT01755026
• Other Study ID Numbers: H-22512
• First Posted: Dec 21, 2012
• Last Update Posted: Aug 21, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Michael Stitely, Adjunct Associate Professor, West Virginia University: Cesarean Delivery; Wound infection; Obesity; Prophylactic antibiotics
• Additional relevant MeSH terms: Wound Infection; Cefazolin

Study Results

Participant Flow

Arm/Group Title	4 Gram Dose	2 Gram Dose of Cefazolin
Arm/Group Description	4 gram dose of pre-operative prophylaxis	2 gram dose of pre-operative cefazolin
Period Title: Overall Study
STARTED	11	12
COMPLETED	9	11
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	4 Gram Dose	2 Gram Dose of Cefazolin	Total
Arm/Group Description	4 gram dose of pre-operative prophylaxis	2 gram dose of pre-operative cefazolin	Total of all reporting groups
Overall Participants	11	12	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 100%	12 100%	23 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.33 (4.64)	31.09 (6.46)	31 (5)
Sex: Female, Male (Count of Participants)
Female	11 100%	12 100%	23 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	11 100%	12 100%	23 100%

Outcome Measures

1. Primary Outcome

Title	Cefazolin Levels
Description	Cefazolin levels
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2 Gram Dose of Cefazolin	4 Gram Dose
Arm/Group Description	2 gram dose of pre-operative cefazolin	4 gram dose of pre-operative prophylaxis
Measure Participants	9	11
Subcutaneous tissue-opening	18.36 (6.68)	40.11 (24.1)
Subcutaneous tissue-closing	21.73 (16.02)	34.89 (17.42)
Plasma concentration at incision	155.45 (50.97)	346.16 (166.01)
Plasma concentration at closure	83.49 (34.97)	150.12 (55.54)
Myometrial levels	67.18 (13.89)	146.22 (60.99)
Umbilical cord blood concentrations	25.01 (12.03)	82.23 (43.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 Gram Dose of Cefazolin, 4 Gram Dose
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	191
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 166.01
	Estimation Comments

Adverse Events

Arm/Group Title	4 Gram Dose		2 Gram Dose of Cefazolin
Arm/Group Description	4 gram dose of pre-operative prophylaxis		2 gram dose of pre-operative cefazolin
All Cause Mortality
	4 Gram Dose		2 Gram Dose of Cefazolin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	4 Gram Dose		2 Gram Dose of Cefazolin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	4 Gram Dose		2 Gram Dose of Cefazolin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		0/12 (0%)
Skin and subcutaneous tissue disorders
Allergy	1/11 (9.1%)	1	0/12 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.