Expired Study
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Galveston, Texas 77550


Purpose:

The purpose of this study is to determine if surgical dressings removed at 24 hours or 48 hours improves wound healing and appearance, and to determine if surgical dressings removed after 24 hours or 48 hours decreases the incidence of post-operative wound infections.


Study summary:

Immediate wound coverage is one of the cornerstones of post-operative wound management. Dressings are typically left in place for 24 to 48 hours following cesarean section to allow ample time for healing and re-epithelialization. The functions of a surgical dressing for wound healing by primary intention are to control postoperative bleeding, absorb exudate, ease pain, and provide protection for newly-formed epithelium. The skin is an important anatomical barrier against microbes; the reformation of an intact epithelial system following injury is an important milestone for the prevention of infection. Wound healing is a dynamic process that involves the coordinated interaction of a variety of cells, including cytokines, blood cells, extracellular matrix proteins, and parenchyma cells. Wound healing has been artificially divided into three phases: inflammation, tissue formation (proliferation), and tissue remodeling. These phases do not correspond to a precise period of time following injury, and all of the phases overlap to some degree. Re-epithelialization occurs during the proliferation phase and it is defined as the process of restoring an intact epidermis after injury. It involves several processes, including the migration and proliferation of adjacent epidermal keratinocytes into the wound, the differentiation of the neo-epithelium into a stratified epidermis, and the restoration of an intact basement membrane zone (BMZ) that will connect the epidermis and the underlying dermis. Re-epithelialization of wounds begins within hours after injury. Within 24 hours, keratinocytes are actively proliferating from the margins of the wound to cover the defect. Surgical wounds that are closed by primary intention usually heal rapidly, and re-epithelialization is thought to occur within 24 to 48 hours. Early studies into wound care demonstrated that dressings influence the repair process. The post-operative wound dressing acts to ensure the wound bed stays moist, decrease pain and inflammation, and improve scar appearance. Additionally, occlusive dressings increase the rate of re-epithelialization post-operatively compared to those wounds left open. The importance of dressings has been established, but the ideal time that postoperative dressings should remain in place remains elusive. Studies have shown that early removal of dressings (6 hours after wounding) markedly decreases the rate of resurfacing, while leaving the bandage on for greater than 48 hours produced no greater benefit. The United States Centers for Disease Control and Prevention recommends that the sterile dressing stay in place for 24-48 hours post-operatively on an incision that has been closed by primary intention. Although the window of benefit provided by bandages has not been further refined since these earlier studies. By defining the period during which dressings will promote epithelial resurfacing, our ability to use the dressing optimally will be enhanced. Our goal of this study is to investigate if there is a difference in outcomes in dressings that are left in place for 24 hours versus 48 hours. While epithelial proliferation begins within hours of closure, it is not at its maximum until 48 to 72 hours following injury. Current standard of care is to keep the dressing in place 24 to 48 hours post-operatively. However, there is no data comparing the optimum timing between 24 and 48 hours. We will therefore assess the benefit of leaving the dressing in place for 24 vs 48 hours post-operatively by evaluating its impact on wound appearance and incidence of surgical site infections using the ASEPSIS scoring method. The ASEPSIS is a quantitative scoring method that provides a numerical score related to the severity of wound infection using objective criteria based on wound appearance and the clinical consequences of the infection. Severity of impaired wound healing is indicated by the total score as follows: satisfactory healing 0 to 10; disturbance of healing 11 to 20; minor wound infection 21 to 30; moderate wound infection 31 to 40; and severe wound infection more than 40.


Criteria:

Inclusion Criteria: - Pregnant Patients between the ages of 18-50 planning to undergo cesarean section for delivery. Exclusion Criteria: - Intra-operative findings suggestive of underlying cancerous condition - Known preoperative infectious disease. - Hysterectomy during cesarean section.


Study is Available At:


Original ID:

14-0548


NCT ID:

NCT02445729


Secondary ID:


Study Acronym:


Brief Title:

Impact of Timing of Wound Dressing Removal After Cesarean Section


Official Title:

Impact of Timing of Wound Dressing Removal After Cesarean Section: Effect of Dressing Removal at 24 Hours Versus 48 Hours on Wound Healing and Incidence of Surgical Site Infections Following Cesarean Section


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The University of Texas Medical Branch, Galveston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

860


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Gokhan S Kilic, MD
Principal Investigator
University of Texas Medical Branch at Galveston

Study Dates

Start Date:March 2015
Completion Date:March 2017
Completion Type:Anticipated
Primary Completion Date:February 2017
Primary Completion Type:Anticipated
Verification Date:May 2016
Last Changed Date:January 12, 2017
First Received Date:May 12, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:ASEPSIS Wound Score
Time Frame:6 Week Follow-Up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:ASEPSIS Wound Score
Time Frame:2 Week Follow-Up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:ASEPSIS Wound Score
Time Frame:1 Week Follow-Up
Safety Issues:False
Outcome Type:Primary Outcome
Measure:ASEPSIS Wound Score
Time Frame:24 or 48 Hours Postoperative
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Dressing removal at 24 hours
Description:Dressing will be removed 24 hours after cesarean section and wounds will be assessed for healing and presence of infection.
Arm Name:Dressing Removal at 24 Hours
Intervention Type:Other
Name:Dressing removal at 48 hours
Description:Dressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection.
Arm Name:Dressing Removal at 48 Hours

Study Arms

Study Arm Type:Active Comparator
Arm Name:Dressing Removal at 48 Hours
Description:These patients are randomly assigned to have their dressing removed 48 hours after cesarean section.
Study Arm Type:Active Comparator
Arm Name:Dressing Removal at 24 Hours
Description:These patients are randomly assigned to have their dressing removed 24 hours after cesarean section.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas Medical Branch, Galveston
Agency Class:Other
Agency Type:Collaborator
Agency Name:Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Wilson AP, Treasure T, Sturridge MF, Grüneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3.
PMID:2868173
Reference Type:Reference
Citation:Wilson AP, Gibbons C, Reeves BC, Hodgson B, Liu M, Plummer D, Krukowski ZH, Bruce J, Wilson J, Pearson A. Surgical wound infection as a performance indicator: agreement of common definitions of wound infection in 4773 patients. BMJ. 2004 Sep 25;329(7468):720.
PMID:15367425
Reference Type:Reference
Citation:Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.
PMID:10196487
Reference Type:Reference
Citation:Baum CL, Arpey CJ. Normal cutaneous wound healing: clinical correlation with cellular and molecular events. Dermatol Surg. 2005 Jun;31(6):674-86; discussion 686. Review.
PMID:15996419
Reference Type:Reference
Citation:Deodhar AK, Rana RE. Surgical physiology of wound healing: a review. J Postgrad Med. 1997 Apr-Jun;43(2):52-6. Review.
PMID:10740722
Reference Type:Reference
Citation:Winter GD. Formation of the scab and the rate of epithelisation of superficial wounds in the skin of the young domestic pig. 1962. J Wound Care. 1995 Sep;4(8):366-7; discussion 368-71.
PMID:7553187
Reference Type:Reference
Citation:HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8.
PMID:14087904
Reference Type:Reference
Citation:Eaglstein WH, Davis SC, Mehle AL, Mertz PM. Optimal use of an occlusive dressing to enhance healing. Effect of delayed application and early removal on wound healing. Arch Dermatol. 1988 Mar;124(3):392-5.
PMID:3345089
Reference Type:Reference
Citation:Hultén L. Dressings for surgical wounds. Am J Surg. 1994 Jan;167(1A):42S-44S; discussion 44S-45S. Review.
PMID:8109684
Reference Type:Reference
Citation:Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. Review.
PMID:17276196
Reference Type:Reference
Citation:National Collaborating Centre for Women's and Children's Health (UK). Surgical Site Infection: Prevention and Treatment of Surgical Site Infection. London: RCOG Press; 2008 Oct.
PMID:21698848
Reference Type:Reference
Citation:Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. Review.
PMID:10471461

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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