NCT02445729

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
869

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

November 10, 2020

Status Verified

June 1, 2019

Enrollment Period

1.9 years

First QC Date

May 12, 2015

Last Update Submit

November 6, 2020

Conditions

Abdominal Wall Wound

Keywords

Cesarean SectionWound Healing

Outcome Measures

Primary Outcomes (1)

  • ASEPSIS Wound Score (1-day)

    24 or 48 Hours Postoperative

Secondary Outcomes (2)

  • ASEPSIS Wound Score (1-day)

    1 Week Follow-Up

  • ASEPSIS Wound Score (1-day)

    6 Week Follow-Up

Other Outcomes (3)

  • Patients' satisfaction

    24 or 48 Hours Postoperative

  • Patients' satisfaction

    1 Week Follow-Up

  • Patients' satisfaction

    6 Week Follow-Up

Study Arms (2)

Dressing Removal at 24 Hours

ACTIVE COMPARATOR

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

Other: Dressing removal at 24 hours

Dressing Removal at 48 Hours

ACTIVE COMPARATOR

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

Other: Dressing removal at 48 hours

Interventions

Dressing removal at 24 hoursOTHER

Dressing will be removed 24 hours after cesarean section and wounds will be assessed for healing and presence of infection.

Dressing Removal at 24 Hours
Dressing removal at 48 hoursOTHER

Dressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection.

Dressing Removal at 48 Hours

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Texas Medical Branch at Galveston

Galveston, Texas, 77550, United States

Location

Etlik Zübeyde Hanim Women's Health Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Dicle University

Diyarbakır, 21280, Turkey (Türkiye)

Location

Related Publications (12)

  • 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.

    PMID: 10471461BACKGROUND

  • 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/

    PMID: 21698848BACKGROUND

  • 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.

    PMID: 17276196BACKGROUND

  • 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.

    PMID: 8109684BACKGROUND

  • 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: 3345089BACKGROUND

  • 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.

    PMID: 14087904BACKGROUND

  • 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.

    PMID: 7553187BACKGROUND

  • Deodhar AK, Rana RE. Surgical physiology of wound healing: a review. J Postgrad Med. 1997 Apr-Jun;43(2):52-6.

    PMID: 10740722BACKGROUND

  • 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.

    PMID: 15996419BACKGROUND

  • 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: 10196487BACKGROUND

  • 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.

    PMID: 15367425BACKGROUND

  • 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.

    PMID: 2868173BACKGROUND

Study Officials

  • Gokhan S Kilic, MD

    The University of Texas Medical Branch, Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 15, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2017

Study Completion

January 31, 2019

Last Updated

November 10, 2020

Record last verified: 2019-06

Locations

TU(2)US(1)