Trial Outcomes & Findings for Prospective Study on Cesarean Wound Outcomes (NCT NCT01697748)

NCT ID: NCT01697748

Last Updated: 2019-11-14

Results Overview

A surgical site infection involving the skin and subcutaneous tissue is defined as either * The presence of a purulent discharge from the wound on inspection, or * Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or * The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 660 participants
• Primary outcome timeframe: from post operative day #1 through post operative day 30
• Results posted on: 2019-11-14

Participant Flow

Recruitment was from September 2013 through June 2016. The 6 week post operative visits were completed August 2016. Recruitment was at University of South Florida South Tampa Campus, Tampa General Hospital Healthpark Genesis and Tampa General Hospital Tampa Florida Labor and Delivery Triage.

3 patients were inadequately consented, two in the Silverlon dressing group and one in the Telfa dressing group

Participant milestones

Measure	Telfa Pad Dressing Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Overall Study STARTED	329	328
Overall Study COMPLETED	271	260
Overall Study NOT COMPLETED	58	68

Reasons for withdrawal

Measure	Telfa Pad Dressing Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Overall Study ineligible skin incision	1	2
Overall Study ineligible uterine incision	4	1
Overall Study Lost to Follow-up	53	65

Baseline Characteristics

Prospective Study on Cesarean Wound Outcomes

Baseline characteristics by cohort

Measure	Telfa Pad Dressing n=329 Participants Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=328 Participants Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Total n=657 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	329 Participants n=5 Participants	328 Participants n=7 Participants	657 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.0 years STANDARD_DEVIATION 5.5 • n=5 Participants	30.9 years STANDARD_DEVIATION 5.6 • n=7 Participants	31.0 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	329 Participants n=5 Participants	328 Participants n=7 Participants	657 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	329 participants n=5 Participants	328 participants n=7 Participants	657 participants n=5 Participants

PRIMARY outcome

Timeframe: from post operative day #1 through post operative day 30

A surgical site infection involving the skin and subcutaneous tissue is defined as either

• The presence of a purulent discharge from the wound on inspection, or
• Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or
• The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.

Outcome measures

Measure	Telfa Pad Dressing n=329 Participants Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=328 Participants Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Percentage of Patients Who Develop a Surgical Site Infection	14 Participants	15 Participants

SECONDARY outcome

Timeframe: Post operative day 7

The following instruments will be used to determine the cosmetic outcome:

• The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)

Outcome measures

Measure	Telfa Pad Dressing n=329 Participants Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=328 Participants Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Cosmetic Outcome of the Cesarean Section Incision	3.8 score on a scale Standard Deviation 1.8	3.7 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Six weeks post-operative

The following instruments will be used to determine the cosmetic outcome

• The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)

Outcome measures

Measure	Telfa Pad Dressing n=329 Participants Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=328 Participants Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Cosmetic Outcome of the Cesarean Section Incision	11.4 score on a scale Standard Deviation 6.5	11.6 score on a scale Standard Deviation 6.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately post operatively to hospital discharge

The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded

Outcome measures

Measure	Telfa Pad Dressing n=329 Participants Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=328 Participants Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Reduction of Pain After Cesarean Delivery	90.0 Morphine milligram equivalent Interval 60.0 to 135.0	82.5 Morphine milligram equivalent Interval 52.5 to 120.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Post operative day 7

Population: This was the number of participants that completed the form at their 7 day post- operative visit.

Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.

Outcome measures

Measure	Telfa Pad Dressing n=299 Participants Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=296 Participants Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
The Number of Participants Noting Pain at the One Week Post Cesarean Visit	23 Participants	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks post operative

Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.

Outcome measures

Measure	Telfa Pad Dressing n=263 Participants Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=242 Participants Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit	5 Participants	8 Participants

Adverse Events

Telfa Pad Dressing

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Silver-impregnated Dressing

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telfa Pad Dressing n=329 participants at risk Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=328 participants at risk Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Skin and subcutaneous tissue disorders Readmission to hospital	0.30% 1/329 • Number of events 1	0.61% 2/328 • Number of events 2

Other adverse events

Measure	Telfa Pad Dressing n=329 participants at risk Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.	Silver-impregnated Dressing n=328 participants at risk Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Skin and subcutaneous tissue disorders Skin reaction to adhesive	0.91% 3/329 • Number of events 3	0.61% 2/328 • Number of events 2

Additional Information

Dr Sheila Connery, Associate Professor Obstetrics and Gynecology

University of South Florida

Phone: 813-259-8542

Email: sconnery@health.usf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee The application was initiated in 12/12. A sponsor subsequently was identified with the addition of objectives to the study. After completion of the University Clinical Trials agreement by both parties and IRB notification, the clinical trials registration was completed with receipt in 8/13. Patients were then consented and the first randomized patient occurred 9/13.
• Publication restrictions are in place

Restriction type: OTHER