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The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

Primary Purpose

Surgical Site Infection

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wound dressing removal.

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

patients ages 18-50 years;
medically competent (no proxies or prisoners); and
multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age.

Exclusion Criteria:

Inability to obtain informed consent;
fetal death;
immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.

Sites / Locations

St. Peter's Hospital
Bellevue Women's Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Wound dressing removal was performed between 12-30 hours postoperatively.

Wound dressing removal was performed between 30-48 hours postoperatively.

Outcomes

Primary Outcome Measures

Surgical Site infection Rate

Cellulitis, purulent drainage, abscess or wound requiring drainage, debridement, and antibiotics associated with a clinical diagnosis of infection. Any disruption of fascia or subcutaneous skin.

Secondary Outcome Measures

Full Information

NCT ID

NCT02902419

First Posted

September 12, 2016

Last Updated

September 14, 2016

Sponsor

Albany Medical College

1. Study Identification

Unique Protocol Identification Number

NCT02902419

Brief Title

The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

Official Title

The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albany Medical College

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A randomized controlled trial measuring surgical site infection rate as a function of timing of wound dressing removal.

Detailed Description

A randomized controlled trial with a sample size of 602 patients to study the effect of timing of wound dressing removal on the surgical site infection rate. 300 patients were randomized to a group that had the wound dressing removed between 12-30 hours postoperatively. 302 patients were randomized to a group that had the wound dressing removal between 30-48 hours postoperatively. Statistical analyses were performed to determine if the timing of dressing removal had statistical significance on the surgical site infection rate, the primary outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

602 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Wound dressing removal was performed between 12-30 hours postoperatively.

Arm Title

Arm Type

Active Comparator

Arm Description

Wound dressing removal was performed between 30-48 hours postoperatively.

Intervention Type

Other

Intervention Name(s)

Wound dressing removal.

Primary Outcome Measure Information:

Title

Surgical Site infection Rate

Description

Cellulitis, purulent drainage, abscess or wound requiring drainage, debridement, and antibiotics associated with a clinical diagnosis of infection. Any disruption of fascia or subcutaneous skin.

Time Frame

6 weeks postoperatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients ages 18-50 years; medically competent (no proxies or prisoners); and multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age. Exclusion Criteria: Inability to obtain informed consent; fetal death; immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Organizational Affiliation

Albany Medical College

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kevin C Kiley, MD

Organizational Affiliation

Albany Medical College

Official's Role

Study Chair

Facility Information:

Facility Name

St. Peter's Hospital

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Bellevue Women's Center

City

Niskayuna

State/Province

New York

ZIP/Postal Code

12309

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22670489

Citation

Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, Wilson EC. Births: final data for 2009. Natl Vital Stat Rep. 2011 Nov 3;60(1):1-70.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

1334987

Citation

Consensus paper on the surveillance of surgical wound infections. The Society for Hospital Epidemiology of America; The Association for Practitioners in Infection Control; The Centers for Disease Control; The Surgical Infection Society. Infect Control Hosp Epidemiol. 1992 Oct;13(10):599-605.

Results Reference

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PubMed Identifier

7842552

Citation

Owen J, Andrews WW. Wound complications after cesarean sections. Clin Obstet Gynecol. 1994 Dec;37(4):842-55. doi: 10.1097/00003081-199412000-00009. No abstract available.

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PubMed Identifier

18510455

Citation

Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol. 2008 Jun;29(6):477-84; discussion 485-6. doi: 10.1086/587810.

Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

Pavlidis TE, Galatianos IN, Papaziogas BT, Lazaridis CN, Atmatzidis KS, Makris JG, Papaziogas TB. Complete dehiscence of the abdominal wound and incriminating factors. Eur J Surg. 2001 May;167(5):351-4; discussion 355. doi: 10.1080/110241501750215221.

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PubMed Identifier

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Citation

Ovington LG. Hanging wet-to-dry dressings out to dry. Home Healthc Nurse. 2001 Aug;19(8):477-83; quiz 484. doi: 10.1097/00004045-200108000-00007.

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PubMed Identifier

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Citation

Chen WY, Rogers AA, Lydon MJ. Characterization of biologic properties of wound fluid collected during early stages of wound healing. J Invest Dermatol. 1992 Nov;99(5):559-64. doi: 10.1111/1523-1747.ep12667378.

Results Reference

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PubMed Identifier

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Citation

Toon CD, Ramamoorthy R, Davidson BR, Gurusamy KS. Early versus delayed dressing removal after primary closure of clean and clean-contaminated surgical wounds. Cochrane Database Syst Rev. 2013 Sep 5;(9):CD010259. doi: 10.1002/14651858.CD010259.pub2.

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PubMed Identifier

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Citation

Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c. Erratum In: Obstet Gynecol. 2013 May;121(5):1113.

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Citation

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Citation

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The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

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