Pain, Postoperative Clinical Trial
Official title:
Pfannenstiel Incision Closure: Subcuticular Suture Versus Surgical Staples
This study compares methods of closure for Pfannenstiel incisions commonly used during
gynecological and obstetrical surgery. Patients are assigned to closure by either surgical
staples or a buried suture. Information is collected on the day of surgery, post-operative
day two and at the six-week follow up visit. The amount of pain and cosmetic result are
compared. Infection rates will also be monitored for the two groups.
The study hypothesis is as follows: subcuticular (buried) sutures as compared to surgical
staples lead to decreased post-operative pain and improved cosmetic result. Infection rates
are similar for both groups.
There is little evidence in the literature to guide the choice of closure material for
Pfannenstiel laparotomy. Currently this decision is based primarily on physician preference.
Physicians differ greatly in their view on which is better. This is based on personal habit
and experience and not on scientific evidence. Specifically in the field of obstetrics and
gynecology there has only been one randomized trial of approximately 60 patients undergoing
cesarean section comparing subcuticular suture vs surgical staples for closure of their
Pfannenstiel skin incisions (Frishman et al., 1997). This study showed that Pfannenstiel
skin incisions closed with subcuticular closure following cesarean section result in less
postoperative pain and are more cosmetically appealing as compared to incisions closed with
staples.
This randomized controlled study will compare closure of Pfannenstiel incisions using either
subcuticular absorbable suture or surgical staples. It will examine two separate populations
- those undergoing cesarean section and those undergoing gynecological surgery such as
hysterectomy. These patient groups will be analyzed separately as their demographic
characteristics tend to be quite different. The primary outcome will be postoperative pain.
Cosmetic result will be a secondary outcome. Cosmesis will be rated both by the patient and
the physician. Infection rates are also of great interest although it is unlikely that this
study will achieve adequate power to show a statistically significant difference in results.
Other outcomes of interest include overall patient satisfaction, total operating room time
and length of hospital stay. Patient's body mass index will also be recorded and analyzed to
determine whether it affects results in both intervention groups.
There will be a minimum of 144 patients total in the cesarean section group and 144 patients
total in the gynecological surgery group - 72 randomized to staples and 72 randomized to
subcuticular suture for each group. Thus the entire study will involve approximately 288
patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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