Abdominal Wall WoundNCT02445729
Impact of Timing of Wound Dressing Removal After Cesarean Section
A study testing Dressing removal at 24 hours and Dressing removal at 48 hours in people with Abdominal Wall Wound, run by The University of Texas Medical Branch, Galveston at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Wall Wound
- What is being tested?
- Dressing removal at 24 hours and Dressing removal at 48 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 869 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2015to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 9Show fewer
- Intraoperative findings suggestive of an underlying cancerous condition,
- Vertical skin incision,
- Planned hysterectomy during CD.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Turkey (Türkiye)2 sites
Etlik Zübeyde Hanim Women's Health Training and Research Hospital
Ankara, 06010
Dicle University
Diyarbakır, 21280
United States1 site
University of Texas Medical Branch at Galveston
Galveston, Texas, 77550
About this study
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
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.
Read the 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.
- Conditions
- Abdominal Wall Wound
- Being tested
- Dressing removal at 24 hours, Dressing removal at 48 hours
- Keywords
- Cesarean Section, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 48 hoursOther
Dressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection.
| Study group | Role | What they receive |
|---|---|---|
| Dressing Removal at 24 Hours | Active comparator | These patients are randomly assigned to have their dressing removed 24 hours after cesarean section. Receives: 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. Receives: Other: Dressing removal at 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASEPSIS Wound Score (1-day)
Measured: 24 or 48 Hours Postoperative
Secondary outcomes (2)
ASEPSIS Wound Score (1-day)
Measured: 1 Week Follow-Up
ASEPSIS Wound Score (1-day)
Measured: 6 Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2017
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall WoundStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 869 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, Dicle University
- Responsible party
- Sponsor
- Investigators
- Gokhan S Kilic, MD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445729
- Sponsor's protocol ID
- 14-0548
- Status last verified
- Jun 2019
- First submitted
- 12 May 2015
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10471461National 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/
PubMed 21698848Li 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.
PubMed 17276196Hulten 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.
PubMed 8109684Eaglstein 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.
PubMed 3345089HINMAN 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.
PubMed 14087904Winter 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.
PubMed 7553187Deodhar AK, Rana RE. Surgical physiology of wound healing: a review. J Postgrad Med. 1997 Apr-Jun;43(2):52-6.
PubMed 10740722Baum 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.
PubMed 15996419Mangram 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.
PubMed 10196487Wilson 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.
PubMed 15367425Wilson 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.
PubMed 2868173
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02445729
- Acronym / sponsor ID
- 14-0548
- Conditions
- Abdominal Wall Wound
- Keywords
- Cesarean Section, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 869 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, Dicle University
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dressing Removal at 24 Hours | Active comparator | Other: Dressing removal at 24 hoursThese patients are randomly assigned to have their dressing removed 24 hours after cesarean section. |
| Dressing Removal at 48 Hours | Active comparator | Other: Dressing removal at 48 hoursThese patients are randomly assigned to have their dressing removed 48 hours after cesarean section. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- low-risk obstetric patients aged 18-44 years with term, singleton pregnancies who planned to have Cesarean Delivery (CD).
- Scheduled nonlabored primary CD for fetal malpresentation,
- Suspected macrosomia,
- Maternal request,
- Placental anomaly,
Key exclusion criteria (9 listed)
- Preeclampsia,
- Preeclampsia with severe features,
- Eclampsia,
- Known preoperative infectious disease, any unknown origin preoperative fever,
- Diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dressing removal at 24 hoursDressing will be removed 24 hours after cesarean section and wounds will be assessed for healing and presence of infection. | Other | Dressing Removal at 24 Hours |
| Dressing removal at 48 hoursDressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection. | Other | Dressing Removal at 48 Hours |
Primary outcome
ASEPSIS Wound Score (1-day)
Time frame: 24 or 48 Hours Postoperative
2 secondary outcomes
ASEPSIS Wound Score (1-day)
Time frame: 1 Week Follow-Up
ASEPSIS Wound Score (1-day)
Time frame: 6 Week Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 10471461Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. doi: 10.1056/NEJM199909023411006. No abstract available.
- Background: PubMed 21698848National 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/
- Background: PubMed 17276196Li 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.
- Background: PubMed 8109684Hulten 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.
- Background: PubMed 3345089Eaglstein 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.
- Background: PubMed 14087904HINMAN 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.
- Background: PubMed 7553187Winter 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.
- Background: PubMed 10740722Deodhar AK, Rana RE. Surgical physiology of wound healing: a review. J Postgrad Med. 1997 Apr-Jun;43(2):52-6.
- Background: PubMed 15996419Baum 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.
- Background: PubMed 10196487Mangram 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.
- Background: PubMed 15367425Wilson 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.
- Background: PubMed 2868173Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokhan S Kilic, MD principal investigator
The University of Texas Medical Branch, Galveston
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing removal at 24 hours and Dressing removal at 48 hours in people with Abdominal Wall Wound, run by The University of Texas Medical Branch, Galveston at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye), United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASEPSIS Wound Score (1-day) (time frame: 24 or 48 Hours Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445729, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.