NCT02445729|CompletedDMC
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Sponsor study identifier
interventional
869
2 countries
3
Study Start
March 2015
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
January 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Actual (reported)May 12, 2015
Actual (reported)May 15, 2015
Actual (reported)February 2017
Actual (reported)January 31, 2019
Actual (reported)ASEPSIS Wound Score (1-day)
24 or 48 Hours Postoperative
ASEPSIS Wound Score (1-day)
1 Week Follow-Up
ASEPSIS Wound Score (1-day)
6 Week Follow-Up
Patients' satisfaction
24 or 48 Hours Postoperative
Patients' satisfaction
1 Week Follow-Up
Patients' satisfaction
6 Week Follow-Up
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.
Dressing will be removed 24 hours after cesarean section and wounds will be assessed for healing and presence of infection.
Dressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection.
University of Texas Medical Branch at Galveston
Galveston, Texas, 77550, United States
Etlik Zübeyde Hanim Women's Health Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Dicle University
Diyarbakır, 21280, Turkey (Türkiye)
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.
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/
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.
Gokhan S Kilic, MD
The University of Texas Medical Branch, Galveston
869 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2015
First Posted
May 15, 2015
Study Start
March 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Deodhar AK, Rana RE. Surgical physiology of wound healing: a review. J Postgrad Med. 1997 Apr-Jun;43(2):52-6.
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.
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.
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.
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.
Primary Completion
February 2017
Actual (reported)Study Completion
January 31, 2019
Actual (reported)Last Updated
November 10, 2020
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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