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Impact of Timing of Wound Dressing Removal After Cesarean Section

Primary Purpose

Abdominal Wall Wound

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dressing removal at 24 hours
Dressing removal at 48 hours
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Abdominal Wall Wound focused on measuring Cesarean Section, Wound Healing

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • low-risk obstetric patients aged 18-44 years with term, singleton pregnancies who planned to have Cesarean Delivery (CD).

CD indications:

  1. Scheduled nonlabored primary CD for fetal malpresentation,
  2. Suspected macrosomia,
  3. Maternal request,
  4. Placental anomaly,
  5. Abnormal / indeterminate fetal heart tracing without labor.
  6. First, second, and third repeat CDs will be included.

Exclusion Criteria:

  1. Preeclampsia,
  2. Preeclampsia with severe features,
  3. Eclampsia,
  4. Known preoperative infectious disease, any unknown origin preoperative fever,
  5. Diabetes,
  6. Pregnant with premature rupture of membrane (PROM) or rupture of membrane (ROM),
  7. Intraoperative findings suggestive of an underlying cancerous condition,
  8. Vertical skin incision,
  9. Planned hysterectomy during CD.

Sites / Locations

  • University of Texas Medical Branch at Galveston
  • Etlik Zübeyde Hanim Women's Health Training and Research Hospital
  • Dicle University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dressing Removal at 24 Hours

Dressing Removal at 48 Hours

Arm Description

These patients are randomly assigned to have their dressing removed 24 hours after cesarean section.

These patients are randomly assigned to have their dressing removed 48 hours after cesarean section.

Outcomes

Primary Outcome Measures

ASEPSIS Wound Score (1-day)

Secondary Outcome Measures

ASEPSIS Wound Score (1-day)
ASEPSIS Wound Score (1-day)

Full Information

First Posted
May 12, 2015
Last Updated
November 6, 2020
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, Dicle University
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1. Study Identification

Unique Protocol Identification Number
NCT02445729
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, Dicle University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess wound healing at 24 vs 48 hours post cesarean delivery with a modified 1-day ASEPSIS score.
Detailed Description
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 postoperative 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 stays in place for 24-48 hours postoperatively on an incision that has been closed by primary intention. Although the window of the 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 compared the impact of dressing removal at 24 vs 48 hours on wounds following low-risk cesarean deliveries. While epithelial proliferation begins within hours of closure, it is not at its maximum until 48 to 72 hours following injury. The current standard of care is to keep the dressing in place 24 to 48 hours postoperatively. 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 postoperatively by evaluating its impact on wound appearance and wound score 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 in 5 days postoperatively. The 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. For practical reasons, absolute scores were obtained based on a 1-day reading in our study, rather than the 5-day reading used in the original ASEPSIS scoring system. Another objective of this study is to evaluate patients' satisfaction according to complaints about their incision. Pain, erythema, induration, separation of skin, and serous or purulent exudates will be documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Wall Wound
Keywords
Cesarean Section, Wound Healing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
869 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dressing Removal at 24 Hours
Arm Type
Active Comparator
Arm Description
These patients are randomly assigned to have their dressing removed 24 hours after cesarean section.
Arm Title
Dressing Removal at 48 Hours
Arm Type
Active Comparator
Arm Description
These patients are randomly assigned to have their dressing removed 48 hours after cesarean section.
Intervention Type
Other
Intervention Name(s)
Dressing removal at 24 hours
Intervention Description
Dressing will be removed 24 hours after cesarean section and wounds will be assessed for healing and presence of infection.
Intervention Type
Other
Intervention Name(s)
Dressing removal at 48 hours
Intervention Description
Dressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection.
Primary Outcome Measure Information:
Title
ASEPSIS Wound Score (1-day)
Time Frame
24 or 48 Hours Postoperative
Secondary Outcome Measure Information:
Title
ASEPSIS Wound Score (1-day)
Time Frame
1 Week Follow-Up
Title
ASEPSIS Wound Score (1-day)
Time Frame
6 Week Follow-Up
Other Pre-specified Outcome Measures:
Title
Patients' satisfaction
Time Frame
24 or 48 Hours Postoperative
Title
Patients' satisfaction
Time Frame
1 Week Follow-Up
Title
Patients' satisfaction
Time Frame
6 Week Follow-Up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: low-risk obstetric patients aged 18-44 years with term, singleton pregnancies who planned to have Cesarean Delivery (CD). CD indications: Scheduled nonlabored primary CD for fetal malpresentation, Suspected macrosomia, Maternal request, Placental anomaly, Abnormal / indeterminate fetal heart tracing without labor. First, second, and third repeat CDs will be included. Exclusion Criteria: Preeclampsia, Preeclampsia with severe features, Eclampsia, Known preoperative infectious disease, any unknown origin preoperative fever, Diabetes, Pregnant with premature rupture of membrane (PROM) or rupture of membrane (ROM), Intraoperative findings suggestive of an underlying cancerous condition, Vertical skin incision, Planned hysterectomy during CD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokhan S Kilic, MD
Organizational Affiliation
University of Texas Medical Branch at Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Etlik Zübeyde Hanim Women's Health Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Dicle University
City
Diyarbakır
ZIP/Postal Code
21280
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
10471461
Citation
Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. doi: 10.1056/NEJM199909023411006. No abstract available.
Results Reference
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PubMed Identifier
21698848
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. Available from http://www.ncbi.nlm.nih.gov/books/NBK53731/
Results Reference
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PubMed Identifier
17276196
Citation
Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. doi: 10.1016/j.clindermatol.2006.09.007.
Results Reference
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PubMed Identifier
8109684
Citation
Hulten L. Dressings for surgical wounds. Am J Surg. 1994 Jan;167(1A):42S-44S; discussion 44S-45S. doi: 10.1016/0002-9610(94)90010-8.
Results Reference
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PubMed Identifier
3345089
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.
Results Reference
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PubMed Identifier
14087904
Citation
HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
Results Reference
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PubMed Identifier
7553187
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. No abstract available.
Results Reference
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PubMed Identifier
10740722
Citation
Deodhar AK, Rana RE. Surgical physiology of wound healing: a review. J Postgrad Med. 1997 Apr-Jun;43(2):52-6.
Results Reference
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PubMed Identifier
15996419
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. doi: 10.1111/j.1524-4725.2005.31612.
Results Reference
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PubMed Identifier
10196487
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.
Results Reference
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PubMed Identifier
15367425
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. doi: 10.1136/bmj.38232.646227.DE. Epub 2004 Sep 14.
Results Reference
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PubMed Identifier
2868173
Citation
Wilson AP, Treasure T, Sturridge MF, Gruneberg 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. doi: 10.1016/s0140-6736(86)90838-x.
Results Reference
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Impact of Timing of Wound Dressing Removal After Cesarean Section

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