Trial Outcomes & Findings for Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples (NCT NCT00524511)

Results Overview

Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

136 participants

Primary outcome timeframe

within six weeks of study intervention

Results posted on

2013-03-05

Participant Flow

September 4, 2007-July 9, 2010 Recruitment occured in the medical clinics and Labor and Delivery unit of an academic medical center

The study design dictates that patients be enrolled upon admission to Labor and Delivery. Subsequently, patients who did not deliver by cesarean delivery would be excluded

Participant milestones

Participant milestones
Measure	Group Receiving Alternative Skin Closure Method (Dermabond) Women receiving Dermabond for skin closure	Group Receiving Standard Skin Closure Method (Surgical Staples Women receiving standard surgical skin staples
Overall Study STARTED	68	68
Overall Study COMPLETED	64	61
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Receiving Alternative Skin Closure Method (Dermabond) n=68 Participants Women receiving Dermabond for skin closure	Group Receiving Standard Skin Closure Method (Surgical Staples n=68 Participants Women receiving standard surgical skin staples	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants	68 Participants n=7 Participants	135 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	68 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: within six weeks of study intervention

Population: No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.

Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before hospital discharge after surgery

Population: No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.

survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)

Outcome measures

Outcome data not reported

Adverse Events

Group Receiving Alternative Skin Closure Method (Dermabond)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group Receiving Standard Skin Closure Method (Surgical Staples

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dawn Tasillo, MD

UMass Memorial Medical Center

Phone: 5083346255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place