Introduction
The US cesarean delivery rate released by the National Center for Health Statistics for 2013 was 32.7%, making it the most frequent operation in women aged 18-44 years performed in the United States. There are several methods of skin closure, one of which involves staples over which an abdominal wound dressing is placed. Wound dressings are important to absorb serous leakage, which protects against infection and maintains an environment conducive to healing.
The incidence of wound complications after cesarean delivery ranges from 2.8-26.6%. Centers for Disease Control and Prevention (CDC) guidelines in 1999 for prevention control of surgical site infections recommended that the primarily closed surgical incision should be covered with a sterile dressing for 24-48 hours. However, it is undetermined whether dressing removal <24 hours increases the risk of surgical site complications.
The purpose of this study was to determine whether early wound dressing removal has an effect on wound complications such as infection, disruption, hematoma, or seroma. Early removal would allow women to wash or shower sooner, and therefore, we were also interested in determining if this increased their satisfaction with their postoperative recovery.
Materials and Methods
This was a randomized, controlled study that was performed from August 2013 through January 2015. Included were low-risk women aged 18-44 years at term with singleton pregnancies having a scheduled nonlabored primary, first repeat, or second repeat cesarean delivery and failed inductions. All patients gave informed written consent. All surgeries were performed under spinal anesthesia. Excluded were women with known pregnancy complications such as fever, diabetes, or preeclampsia, and patients who had labored or with prelabor rupture of membranes. To further decrease confounders, also excluded were women with a body mass index ≥35.
Randomization was by computer-generated blocks of 2. Women were randomized for wound dressing removal at either 6 or 24 hours postsurgery. Six hours was chosen as this is the time all women were routinely moved from their bed to a chair. The primary outcome was the incidence of a wound complication, defined as infection, wound disruption (skin dehiscence or deeper), or seroma/hematoma. Women having >1 complication were categorized as the more significant in the order given above. Women were permitted to wash or shower after wound dressing removal, and our secondary outcome was patient satisfaction with their postoperative care measured by a questionnaire.
All cesarean deliveries were performed in a similar fashion. All women received a single-dose prophylactic antibiotic within 1 hour of skin incision. All abdominal preparations were by povidone iodine 7.5% soap scrub followed by povidone iodine 10%, ethanol 65% wash. Skin incisions were all Pfannenstiel. Intraabdominal adhesion barriers were not used. The bladder flap, rectus muscles, and parietal peritoneum were not closed. Closure of the fascia was by Vicryl (Ethicon, Somerville, NJ) for first cesarean deliveries and polydioxanone (Ethicon) for repeat cesarean deliveries. Subcutaneous tissue was closed if the depth was >2 cm. Skin incisions were closed using staples. A standard adhesive nonwoven wound dressing (Pharmapore Sterile; Pharmaplast, Alexandria, Egypt) was applied.
Nurses removed the wound dressing at the designated time. All women were moved to a chair at 6 hours postoperatively. Bladder catheters were removed at 6-12 hours. Use of the bathroom for personal hygiene (washing or showering) was permitted only after wound dressing removal (6 or 24 hours). Nurses recorded the time of bathroom use for washing or showering. Women were routinely discharged on postoperative day 3 or 4 unless requiring intravenous antibiotics.
Prior to discharge, women were reminded of the 2 arms of this study, and were asked “What is the level of satisfaction with the timing of your dressing removal and your ability to wash or shower thereafter.” The 3 possible responses were pleased/satisfied, no difference, and displeased/unsatisfied.
Wounds were examined prior to discharge for evidence of any complication. Postoperative intravenous antibiotics were started in women with various indications such as fever, endometritis, or wound infection, but were counted as the latter only in the presence of induration or purulent discharge from the incision site.
Following discharge, staples were removed on postoperative day 5-7 in outpatient clinics at the discretion of the physicians. The provider, who was unaware of the patient’s group designation, assessed the incision site for wound complications and this information was telephoned or mailed to the investigators. Seroma was defined as a subcutaneous collection of clear or lightly blood-tinged fluid. Hematoma was diagnosed in the presence of blood and clot. Wound infection was diagnosed if there was purulent discharge, and dehiscence or disruption if there was clear separation of superficial or deep layers. Women were readmitted if intravenous antibiotics were deemed necessary.
Patient’s demographics were obtained at the time of inclusion. The variable distributions were checked for the continuous variables, and if normally distributed, unpaired t testing was performed. If the variables did not pass normality testing, then nonparametric testing was used. Unadjusted categorical variables were compared using Fisher exact test and odds ratio and the 95% confidence interval were calculated. A P < .05 was considered statistically significant. The data were analyzed using software (SPSS, Version 20.0.0.2; IBM Corp, Armonk, NY).
For sample size calculation, we used an estimation of 12% of wound complications after the standard 24-hour dressing removal. For the 6-hour dressing removal to increase the wound complication rate by 100% from 12-24% with α of 0.05 and power of 80%, we needed 160 women in each arm. A 50% increase from 12-18% would have required 1100 total women. This study was approved by the institutional review board of Ziv Medical Center and registered at Clinicaltrials.gov ( NCT01867567 ).
Materials and Methods
This was a randomized, controlled study that was performed from August 2013 through January 2015. Included were low-risk women aged 18-44 years at term with singleton pregnancies having a scheduled nonlabored primary, first repeat, or second repeat cesarean delivery and failed inductions. All patients gave informed written consent. All surgeries were performed under spinal anesthesia. Excluded were women with known pregnancy complications such as fever, diabetes, or preeclampsia, and patients who had labored or with prelabor rupture of membranes. To further decrease confounders, also excluded were women with a body mass index ≥35.
Randomization was by computer-generated blocks of 2. Women were randomized for wound dressing removal at either 6 or 24 hours postsurgery. Six hours was chosen as this is the time all women were routinely moved from their bed to a chair. The primary outcome was the incidence of a wound complication, defined as infection, wound disruption (skin dehiscence or deeper), or seroma/hematoma. Women having >1 complication were categorized as the more significant in the order given above. Women were permitted to wash or shower after wound dressing removal, and our secondary outcome was patient satisfaction with their postoperative care measured by a questionnaire.
All cesarean deliveries were performed in a similar fashion. All women received a single-dose prophylactic antibiotic within 1 hour of skin incision. All abdominal preparations were by povidone iodine 7.5% soap scrub followed by povidone iodine 10%, ethanol 65% wash. Skin incisions were all Pfannenstiel. Intraabdominal adhesion barriers were not used. The bladder flap, rectus muscles, and parietal peritoneum were not closed. Closure of the fascia was by Vicryl (Ethicon, Somerville, NJ) for first cesarean deliveries and polydioxanone (Ethicon) for repeat cesarean deliveries. Subcutaneous tissue was closed if the depth was >2 cm. Skin incisions were closed using staples. A standard adhesive nonwoven wound dressing (Pharmapore Sterile; Pharmaplast, Alexandria, Egypt) was applied.
Nurses removed the wound dressing at the designated time. All women were moved to a chair at 6 hours postoperatively. Bladder catheters were removed at 6-12 hours. Use of the bathroom for personal hygiene (washing or showering) was permitted only after wound dressing removal (6 or 24 hours). Nurses recorded the time of bathroom use for washing or showering. Women were routinely discharged on postoperative day 3 or 4 unless requiring intravenous antibiotics.
Prior to discharge, women were reminded of the 2 arms of this study, and were asked “What is the level of satisfaction with the timing of your dressing removal and your ability to wash or shower thereafter.” The 3 possible responses were pleased/satisfied, no difference, and displeased/unsatisfied.
Wounds were examined prior to discharge for evidence of any complication. Postoperative intravenous antibiotics were started in women with various indications such as fever, endometritis, or wound infection, but were counted as the latter only in the presence of induration or purulent discharge from the incision site.
Following discharge, staples were removed on postoperative day 5-7 in outpatient clinics at the discretion of the physicians. The provider, who was unaware of the patient’s group designation, assessed the incision site for wound complications and this information was telephoned or mailed to the investigators. Seroma was defined as a subcutaneous collection of clear or lightly blood-tinged fluid. Hematoma was diagnosed in the presence of blood and clot. Wound infection was diagnosed if there was purulent discharge, and dehiscence or disruption if there was clear separation of superficial or deep layers. Women were readmitted if intravenous antibiotics were deemed necessary.
Patient’s demographics were obtained at the time of inclusion. The variable distributions were checked for the continuous variables, and if normally distributed, unpaired t testing was performed. If the variables did not pass normality testing, then nonparametric testing was used. Unadjusted categorical variables were compared using Fisher exact test and odds ratio and the 95% confidence interval were calculated. A P < .05 was considered statistically significant. The data were analyzed using software (SPSS, Version 20.0.0.2; IBM Corp, Armonk, NY).
For sample size calculation, we used an estimation of 12% of wound complications after the standard 24-hour dressing removal. For the 6-hour dressing removal to increase the wound complication rate by 100% from 12-24% with α of 0.05 and power of 80%, we needed 160 women in each arm. A 50% increase from 12-18% would have required 1100 total women. This study was approved by the institutional review board of Ziv Medical Center and registered at Clinicaltrials.gov ( NCT01867567 ).