Comparison of Surgical Skin Preps During Cesarean Deliveries
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| ClinicalTrials.gov Identifier: NCT01870583 |
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Recruitment Status :
Completed
First Posted : June 6, 2013
Results First Posted : June 19, 2017
Last Update Posted : October 2, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Surgical Site Infection Following Cesarean Delivery | Drug: Iodine povidone Drug: Chlorhexidine Drug: Combination iodine and chlorhexidine | Not Applicable |
Currently the skin preparation solutions currently in use for cesarean delivery are chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no recommendations of which surgical skin prep wound be best utilized for cesarean delivery, especially if the patient has risk factors for surgical site infection. Chlorhexidine solution has been reported to take minimal of 2 minutes after application to decrease the bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone solution has been reported to be completely effective within 4 minutes of application. Patient's risk factor for surgical site infection, including obesity, history of incision complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin prep to be applied. Finally, the majority of postpartum infections manifest after hospital discharge and most of these post-discharge infections are diagnosed and treated entirely in the ambulatory setting, without the patients' returning to the hospital.
The purpose of the study is:
- To compare chlorhexidine based solution, iodine povidone solution, and combination of both agents in cesarean delivery skin preparation solution for prevention of surgical site infection (SSI)
- To determine if surgical site infection (SSI) risk factors should guide selection of one specific surgical skin preparation solution.
This will be a prospective randomized observational study of the women presenting for care to the Montefiore Medical Center. All patients will undergo routine obstetrical care and preparation for cesarean delivery as if they were not participating in this research study. All patients in the study will receive the pre-operative intravenous antibiotics pre-operatively as part of departmental protocol for cesarean delivery.
The patients will be randomized after informed consent obtained into one of three groups: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Sequentially numbered envelopes will contain the group of randomization for the patient created by a computer generated program which will occur prior to commencement of the study.
Surgical preparation will follow the departmental protocol as if the patient were not in the study with exception of the skin preparation. Once the patient is randomized to the skin preparation group, the corresponding skin preparation solution will be used in accordance to manufacturer's guidelines for the product and Departmental protocol. If randomized to group 3 (combination), the iodine based preparation will occur first followed by the chlorhexidine based skin preparation. All groups will wait a minimal of 4 minutes prior to skin incision after application of skin prep, and all patients will be surgically draped with the standard drapes as if not participating in a study. Cesarean delivery will occur following the technique of the surgeon, including skin closure method, suture or staples.
All patients will be followed until the routine postpartum visit occurs at 6-8 weeks following delivery. Postpartum visit information will be extracted from the medical record. If no postpartum visit occurs, the patient will be contacted by telephone at 8 weeks post delivery and asked about any incisional complications which may have occurred and required treatment by as physician or healthcare provider in the office or hospital.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1404 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Comparison of Surgical Skin Preps During Cesarean Deliveries |
| Study Start Date : | February 2013 |
| Actual Primary Completion Date : | July 2014 |
| Actual Study Completion Date : | July 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Combination iodine and chlorhexidine
The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
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Drug: Combination iodine and chlorhexidine
Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery |
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Active Comparator: Chlorhexidine
Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
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Drug: Chlorhexidine
Chlorhexidine skin preparation solution prior to cesarean delivery |
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Active Comparator: Iodine povidone
Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
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Drug: Iodine povidone
Iodine skin preparation solution prior to cesarean delivery |
- Cesarean Surgical Site Infection [ Time Frame: 42 days after delivery ]Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gestational age > 37 weeks 0/7 days
- Non-emergency indication for cesarean
Exclusion Criteria:
- Urogenital tract infection within 2 weeks prior to surgery
- Chronic oral or injectable steroid use (> 2 weeks)
- Emergency cesarean delivery
- Participation in another research study
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): NCT01870583
| United States, New York | |
| Montefiore Medical Center Weiler Division | |
| The Bronx, New York, United States, 10461 | |
| Montefiore Medical Center Wakefield Division | |
| The Bronx, New York, United States, 10466 | |
| Study Chair: | David A Wallach, CIP | Einstein IRB |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Garry, Co-Director Obstetrics & MFM service Wakefield Division, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT01870583 |
| Other Study ID Numbers: |
CCI#12-07-248 |
| First Posted: | June 6, 2013 Key Record Dates |
| Results First Posted: | June 19, 2017 |
| Last Update Posted: | October 2, 2017 |
| Last Verified: | September 2017 |
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Cesarean delivery Surgical site infection Pregnancy Postpartum |
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Surgical Wound Infection Infections Wound Infection Postoperative Complications Pathologic Processes Iodine Chlorhexidine Chlorhexidine gluconate Cadexomer iodine Povidone |
Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents Trace Elements Micronutrients Physiological Effects of Drugs Plasma Substitutes Blood Substitutes |