Cesarean Trial of Staples vs. Sutures

Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.

• Staples (Other), also known as Closure Technique: Interrupted Ethicon Staples
• Suture (Other), also known as Closure Technique: Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Primary outcomes

• Number of Participants With Wound Complications [Within 6 weeks of postpartum]: The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.

Secondary outcomes

• Patient Scar Assessment Scale Scores for Evaluation of Cosmesis [Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.]: Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures. Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior.
• Patient Satisfaction With Closure Method and Scar Appearance [Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.]: Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied.
• Pain Perception [Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean]: Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions.
• Additional Provider Visits [Within 6 weeks postpartum]: Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication).
• Number of Participants With Primary Versus Repeat Cesarean [At randomization.]: Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)
• Intraoperative Trial Details - Duration of Operation and Skin Closure [Time of Cesarean]: Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure
• Intraoperative Trial Details - Closure of Subcutaneous Tissue [Time of Cesarean]: Number of participants requiring subcutaneous tissue closure
• Length of Hospital Stay [Immediate postpartum.]: Length of hospital stay (days)
• Number of Participants That Received Anticoagulation Within 24 Hours [Within 24 hours postpartum.]: Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)
• Number of Participants Diagnosed With Endomyometritis [Immediate postpartum.]: Number of participants diagnosed with endomyometritis requiring antibiotics
• Change in Hemoglobin Pre-operatively to Post-operatively [Up to 72 hours before and 24 hours after cesarean.]: Median change in hemoglobin from preoperative value (g/dL) to post-operatively.
• Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. [Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.]: Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior.

Sex: Female, accepts healthy volunteers

Inclusion Criteria:

* Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

Exclusion Criteria:

* Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels > 95 and 120 respectively within the week prior to delivery),
* Vertical skin incisions
* Chronic steroid use
* Active lupus flare
* HIV/AIDS
* Current treatment for cancer or a history of radiation to the abdomen/pelvis
* Current treatment with immunosuppressant medications secondary to history of transplantation
* Emergency cesarean(precluding informed consent prior to surgery)
* Lack of access to a phone
* Allergy to suture or staple material

Participant flow

Outcome results

• Number of Participants With Wound Complications (Primary), Count of participants, Participants: Suture 18; Staples 40
• Patient Scar Assessment Scale Scores for Evaluation of Cosmesis (Secondary), Median, score on a scale: Suture 15 (10 to 25); Staples 20 (11 to 28)
• Patient Satisfaction With Closure Method and Scar Appearance (Secondary), Median, score on a scale: Staples 9 (6 to 10); Suture 10 (9 to 10)
• Pain Perception (Secondary), Median, score on a scale: Suture 3.5 (2.0 to 5.0); Staples 3.6 (2.2 to 5.0)
• Additional Provider Visits (Secondary), Mean, Number of Visits per participant: Suture .9 (0 to 7); Staples 1.5 (0 to 7)
• Number of Participants With Primary Versus Repeat Cesarean (Secondary), Count of participants, Participants: Suture 109; Staples 106
• Intraoperative Trial Details - Duration of Operation and Skin Closure (Secondary), Median, Minutes: Suture 58.5 (46.5 to 75); Staples 51 (40 to 65)
• Intraoperative Trial Details - Closure of Subcutaneous Tissue (Secondary), Count of participants, Participants: Suture 201; Staples 202
• Length of Hospital Stay (Secondary), Median, Days: Suture 4.4 (1 to 8); Staples 4.5 (3 to 14)
• Number of Participants That Received Anticoagulation Within 24 Hours (Secondary), Count of participants, Participants: Suture 14; Staples 17
• Number of Participants Diagnosed With Endomyometritis (Secondary), Count of participants, Participants: Suture 11; Staples 7
• Change in Hemoglobin Pre-operatively to Post-operatively (Secondary), Median, g/dL: Suture -1.8 (-2.5 to -1.2); Staples -1.8 (-2.5 to -1.1)
• Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. (Secondary), Median, score on a scale: Suture 12 (9 to 15); Staples 13 (9 to 16)

Adverse events

Time frame: Adverse events were monitored from the time of randomization to 30 days postpartum.

Other adverse events by term

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• Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30. PMID 9350017
• Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577. PMID 12804476
• Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011. PMID 20816153
• Results publication: Mackeen AD, Khalifeh A, Fleisher J, Han C, Leiby B, Berghella V. Pain Associated With Cesarean Delivery Skin Closure: A Randomized Controlled Trial. Obstet Gynecol. 2015 Oct;126(4):702-707. doi: 10.1097/AOG.0000000000001043. PMID 26348166
• Results publication: Mackeen AD, Khalifeh A, Fleisher J, Vogell A, Han C, Sendecki J, Pettker C, Leiby BE, Baxter JK, Sfakianaki A, Berghella V. Suture compared with staple skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1169-1175. doi: 10.1097/AOG.0000000000000227. PMID 24807325

• A. Dhanya Mackeen, MD, MPH, Principal investigator, Thomas Jefferson University