Wound Complication, Wound Infection
Conditions
Keywords
Wound infection, Wound separation, Skin staples, Subcuticular suture
Brief summary
Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.
Detailed description
The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI\>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.
Interventions
DEVICE4-0 monofilament suture
Skin closure using 4-0 monofilament suture
DEVICEStainless steel staples
Skin closure using stainless steel staples.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All women, \>=18 and \<= 85 years of age, undergoing surgery, via a midline laparotomy. * Body mass index \>=30 * Benign or oncologic indications for surgery. * Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery. * Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine. * Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion criteria
* Women who are pregnant or breastfeeding * Pfannenstiel or transverse abdominal incision * Concomitant panniculectomy or plastic surgery * Women \<18 years of age * History of prior abdominal or pelvic radiation * Inability to sign an informed consent form prior to registration on study * Inability to understand spoken or written English * Prisoner * Mental incapacity * A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. | 4-8 weeks post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Wound Infection | 4-8 weeks post-surgery | Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection. |
| Operative Time | During surgery | Time from skin incision to the end of skin closure |
| Incidence of Wound Disruption | 4-8 weeks post-surgery | — |
| Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score | 4-8 weeks post-operative | * Ranges from 0 (worst) to 5 (best) * Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0 |
| Median Patient Satisfaction Score of Scar Appearance | 4-8 weeks post-operative | Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated very unsatisfied or 0% and the end of the line was very satisfied or 100%. |
| Analog Pain Score on Postoperative Days 3-4 | 3-4 days post-surgery | The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively. |
Countries
United States
Participant flow
Pre-assignment details
173 participants were enrolled to the study but 8 participants had a change in their surgical procedure which deemed them ineligible for study enrollment and were excluded from the study before randomization to the arms.
Participants by arm
| Arm | Count |
|---|---|
| Stainless Steel Staples Skin closure using stainless steel staples. | 84 |
| 4-0 Monofilament Sutures Skin closure using 4-0 monofilament sutures | 79 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Stainless Steel Staples | 4-0 Monofilament Sutures | Total |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 13.2 | 57.1 years STANDARD_DEVIATION 11.2 | 57.4 years STANDARD_DEVIATION 12.3 |
| American Society of Anesthesiologists (ASA) class 1-2 | 39 Participants | 47 Participants | 86 Participants |
| American Society of Anesthesiologists (ASA) class 3-4 | 45 Participants | 32 Participants | 77 Participants |
| Body mass index (BMI) 30-39.9 | 60 Participants | 49 Participants | 109 Participants |
| Body mass index (BMI) 40-49.9 | 19 Participants | 24 Participants | 43 Participants |
| Body mass index (BMI) 50 or greater | 5 Participants | 6 Participants | 11 Participants |
| Cardiovascular disease | 58 Participants | 57 Participants | 115 Participants |
| Diabetes mellitus | 27 Participants | 19 Participants | 46 Participants |
| Indications for surgery Benign | 22 Participants | 27 Participants | 49 Participants |
| Indications for surgery Other | 11 Participants | 5 Participants | 16 Participants |
| Indications for surgery Ovarian/fallopian/peritoneal cancer | 24 Participants | 21 Participants | 45 Participants |
| Indications for surgery Synchronous primary | 3 Participants | 3 Participants | 6 Participants |
| Indications for surgery Uterine cancer | 24 Participants | 23 Participants | 47 Participants |
| Prior Abdominal Surgery | 51 Participants | 53 Participants | 104 Participants |
| Prior malignancy | 7 Participants | 8 Participants | 15 Participants |
| Pulmonary disease | 20 Participants | 27 Participants | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 19 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 68 Participants | 60 Participants | 128 Participants |
| Region of Enrollment United States | 84 participants | 79 participants | 163 participants |
| Sex: Female, Male Female | 84 Participants | 79 Participants | 163 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tobacco Use Current | 7 Participants | 5 Participants | 12 Participants |
| Tobacco Use Former | 33 Participants | 15 Participants | 48 Participants |
| Tobacco Use Never | 44 Participants | 59 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 84 | 0 / 79 |
| serious Total, serious adverse events | 0 / 84 | 0 / 79 |
Outcome results
Primary
Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.
Time frame: 4-8 weeks post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stainless Steel Staples | Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. | 28 Participants |
| 4-0 Monofilament Sutures | Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. | 25 Participants |
Secondary
Analog Pain Score on Postoperative Days 3-4
The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.
Time frame: 3-4 days post-surgery
Population: Data was not collected from any patients for this outcome measure
Secondary
Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score
* Ranges from 0 (worst) to 5 (best) * Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0
Time frame: 4-8 weeks post-operative
Population: -Data was not collected from 10 patients in the Stainless Steel Staple arm and 9 patients in the 4-0 Monocryl Suture arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stainless Steel Staples | Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score | 4 units on a scale |
| 4-0 Monofilament Sutures | Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score | 5 units on a scale |
Secondary
Incidence of Wound Disruption
Time frame: 4-8 weeks post-surgery
Population: -Data on incidence of wound disruption was not collected on 9 patients in the stainless steel staple arm and 9 patients in the 4-0 Monocryl suture arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stainless Steel Staples | Incidence of Wound Disruption | 21 Participants |
| 4-0 Monofilament Sutures | Incidence of Wound Disruption | 13 Participants |
Secondary
Incidence of Wound Infection
Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.
Time frame: 4-8 weeks post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stainless Steel Staples | Incidence of Wound Infection | 1 Participants |
| 4-0 Monofilament Sutures | Incidence of Wound Infection | 1 Participants |
Secondary
Median Patient Satisfaction Score of Scar Appearance
Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated very unsatisfied or 0% and the end of the line was very satisfied or 100%.
Time frame: 4-8 weeks post-operative
Population: -Data was not collected on 13 patients in the Stainless Steel Staple arm and 12 patients in the 4-0 Monocryl Suture arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stainless Steel Staples | Median Patient Satisfaction Score of Scar Appearance | 68 Patient Satisfaction Score |
| 4-0 Monofilament Sutures | Median Patient Satisfaction Score of Scar Appearance | 77 Patient Satisfaction Score |
Secondary
Operative Time
Time from skin incision to the end of skin closure
Time frame: During surgery
Population: Data was not collected from 3 patients in the stainless steel staple arm and 1 patient in the 4-0 Monocryl suture arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stainless Steel Staples | Operative Time | 3 minutes |
| 4-0 Monofilament Sutures | Operative Time | 11 minutes |